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Copyright of Gynäkologische Endokrinologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Despite advances in pharmacological therapies, migraine patients are often drug resistant. Further therapeutic options in this field are, therefore, desirable. Recent studies have highlighted the efficacy of ketogenic diet (KD) on improving migraine, but data on their long-term efficacy and safety are lacking. In this study, we retrospectively evaluated the long-term effectiveness of the modified Atkins ketogenic diet (MAD) in episodic or chronic drug-resistant migraine patients. 52 patients diagnosed with episodic or chronic drug-resistant migraine under modified Atkins ketogenic diet (MAD) were evaluated. In total, 41 patients followed the diet for 6 months and 33 for 12 months. After both 6 and 12 months, frequency, length, and intensity of migraine episodes, as well as the number of medications significantly decreased with respect to the start of the diet. Body mass index, high sensitivity PCR, diastolic blood pressure, fasting plasma insulin and HOMA index were also significantly reduced both after 6 and 12 months. No major metabolic changes were observed during MAD treatment. In conclusion, KD has been shown to be effective and safe in the long-term treatment of drug-resistant migraine. A high dropout rate still remains an important factor, which often limits its use. [ABSTRACT FROM AUTHOR]

Introduction: The term 'refractory migraine' (RM) is commonly used in clinical settings; however, it is not recognized in the International Classification of Headache Disorders, third edition. A growing need for a shared definition of refractoriness has been highlighted by a multidisciplinary expert group. Although definitions for RM currently exist, the key parameters for the definition of refractoriness (e.g., unresponsiveness to treatment, high frequency, severe disability, or all of these features) remain contentious. Thus, a consensus on the definition of RM is crucial. Methods: Calcitonin gene‐related peptide (CGRP) is a neuropeptide that plays an important role in migraine pathophysiology and is a target for migraine preventive therapies. Monoclonal antibodies targeting the CGRP (i.e., galcanezumab, fremanezumab, and eptinezumab) and its receptor (erenumab) have shown consistent efficacy for migraine prophylaxis with excellent safety profiles. Their effect on refractory cases has also been reported, offering promise to the many patients who have not found relief with existing treatments. Therefore, we anticipate a paradigm shift in migraine treatment. Results: Following the widespread use of monoclonal antibodies targeting the CGRP and its receptor, the European Headache Federation proposed a definition for two subsets of difficult‐to‐treat migraine—resistant and refractory migraine—that considers both the frequency and disability caused by single and frequent attacks. Conclusion: We expect that this definition will help resolve previous conflicts that have limited the use of earlier definitions. [ABSTRACT FROM AUTHOR]

Background: Headache disorders, particularly primary headaches like migraine and tension-type headache, still remain underdiagnosed and undertreated despite their high prevalence and significant impact on quality of life. In recent years, several specific medications targeting key pathways in the pathophysiology of migraine have been developed. Despite this advancement, numerous studies indicate that non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics remain the most commonly used drugs. This study focused on the use of NSAIDs and simple analgesics as acute treatments for migraine among patients at a tertiary headache center. Methods: A retrospective observational study was conducted at the Fondazione Policlinico Universitario Campus Bio-Medico throughout 2022. Data were collected on the type and frequency of headaches, the usage and dosage of NSAIDs and other medications, and changes in their use at follow-up visits. Statistical analyses were performed to evaluate the efficacy and determinants of NSAID consumption and headache frequency changes. Results: Two hundred and eightythree patients diagnosed with migraine undergoing their first examination at our center were enrolled. Initially, 58.7% of patients used NSAIDs or simple analgesics, which decreased to 46.6% 3 months after, while triptan use increased from 65.1 to 72.8%. Changes in prophylactic therapies were significantly associated with a decrease in NSAID intake (W = 834.000, p = 0.004) and in headache frequency (W = 5960.5, p = 0.003). Specifically, the addition of topiramate or amitriptyline was associated with a reduction in NSAID use and headache frequency. Even pain freedom after the intake of NSAIDs improved from 55.2 to 79.4% of cases at follow-up. Conclusion: The study highlights the importance of appropriate diagnosis and tailored treatment strategies in the management of primary headaches. It underscores the need for specialized care to enhance treatment efficacy and patient outcomes, demonstrating that adjustments in prophylactic therapy can significantly reduce NSAID intake and improve headache care. This reinforces the role of tertiary headache centers in providing specialized care that can adapt treatments to individual patient needs and improve overall headache management. [ABSTRACT FROM AUTHOR]

Purpose of Review: Calcitonin gene-related peptide (CGRP) pathway modulators, such as atogepant, represent a novel therapeutic option for the treatment of migraines. We performed a systematic review and meta-analysis to evaluate the effects of 12-week treatment with atogepant compared with placebo in patients with migraine. Recent Findings: A total of four RCTs and 3,140 patients were included, of whom 2,306 were prescribed atogepant. Compared with placebo, atogepant significantly reduced monthly migraine days (WMD -1.27; 95% CI -1.71,-0.83; p < 0.01), days with acute medication use (WMD -1.49; 95% CI -1.96,-1.02; p < 0.01), and monthly headache days (WMD -1.53; 95% CI -1.90,-1.15; p < 0.01). In the subgroup analysis of those outcomes, overall results were similar between groups. There was a significant increase in nausea (RR 2.23; 95% CI 1.43, 3.48; p < 0.01) and constipation (RR 3.57; 95% CI 1.62, 7.89; p < 0.01) in the atogepant-treated group. There were no significant differences in nasopharyngitis, upper airway infection, urinary tract infection, fatigue, serious adverse events, and discontinuation of treatment due to adverse events. Summary: This meta-analysis of RCTs suggests that atogepant is effective in the reduction of migraine episodes among patients with migraine headaches, albeit with an increase in nausea and constipation relative to placebo. [ABSTRACT FROM AUTHOR]

Migraine, a complex neurological disorder, affects a significant portion of the population and presents both medical and societal challenges. The aim of this paper is to provide a detailed review and analysis of available therapeutic methods for patients suffering from migraines, considering both pharmacological and non-pharmacological therapies. The approaches presented include acute treatment with triptans and nonsteroidal anti-inflammatory drugs (NSAIDs), as well as preventive therapies, such as beta-blockers and antiepileptic drugs. The section on non-pharmacological therapies focuses on cognitive-behavioral therapy (CBT), biofeedback, and lifestyle recommendations, including diet and sleep hygiene. A review of the literature indicates that integrating pharmacological and non-pharmacological approaches can significantly improve treatment effectiveness and the quality of life for patients with migraines.

BackgroundHeadache disorders, particularly primary headaches like migraine and tension-type headache, still remain underdiagnosed and undertreated despite their high prevalence and significant impact on quality of life. In recent years, several specific medications targeting key pathways in the pathophysiology of migraine have been developed. Despite this advancement, numerous studies indicate that non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics remain the most commonly used drugs. This study focused on the use of NSAIDs and simple analgesics as acute treatments for migraine among patients at a tertiary headache center.MethodsA retrospective observational study was conducted at the Fondazione Policlinico Universitario Campus Bio-Medico throughout 2022. Data were collected on the type and frequency of headaches, the usage and dosage of NSAIDs and other medications, and changes in their use at follow-up visits. Statistical analyses were performed to evaluate the efficacy and determinants of NSAID consumption and headache frequency changes.ResultsTwo hundred and eightythree patients diagnosed with migraine undergoing their first examination at our center were enrolled. Initially, 58.7% of patients used NSAIDs or simple analgesics, which decreased to 46.6% 3 months after, while triptan use increased from 65.1 to 72.8%. Changes in prophylactic therapies were significantly associated with a decrease in NSAID intake (W = 834.000, p = 0.004) and in headache frequency (W = 5960.5, p = 0.003). Specifically, the addition of topiramate or amitriptyline was associated with a reduction in NSAID use and headache frequency. Even pain freedom after the intake of NSAIDs improved from 55.2 to 79.4% of cases at follow-up.ConclusionThe study highlights the importance of appropriate diagnosis and tailored treatment strategies in the management of primary headaches. It underscores the need for specialized care to enhance treatment efficacy and patient outcomes, demonstrating that adjustments in prophylactic therapy can significantly reduce NSAID intake and improve headache care. This reinforces the role of tertiary headache centers in providing specialized care that can adapt treatments to individual patient needs and improve overall headache management.

Copyright of Ege Journal of Medicine is the property of Ege University, Faculty of Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Migraine is a common cause of disability and loss of work. Migraine attacks are a complex brain event that unfolds over hours to days, in a recurrentmanner.A high frequency of migraine attacks can lead to frequent intake of acute medication, which may result in medication-overuse headache. Therefore, prophylaxis of migraine is justified as an important goal. Objective: To study and compare the clinical effectiveness and side effects of various migraine prophylactic drugs. Materials and methods: The patients fulfilling the inclusion and exclusion criteria were enrolled into this randomized, single blind study carried out in the patients visiting the Neurology OPD of Gauhati Medical College and Hospital, Guwahati from November 2022 to October 2023and were prescribed one of the following migraine prophylactic drugs-propranolol, amitriptyline, divalproex and desvenlafaxine. The initial four weeks were used for drug dose titration to minimum effective or maximum tolerable dosage and after optimal dose titration, the following 12 weeks were used to assess the efficacy of the drugs. MIDAS(Migraine Disability Assessment Score) questionnaire and Headache Impact Test-6(HIT-6) along with drug diary were used to assess the pre and post drug intervention quality of life which will help in assessing the efficacy of the drugs being used. Results: The study had a total of 100 patients with a median age of 28 years, with most of the patients presenting in the third decade of life. The male to female ratio was 1:2.3. The mean MIDAS scores at day 0 and at 3 months for the propranolol group were 18.9 and 7.20; for amitriptyline group it was 16.43 and 8.21, for divalproex it was 16.28 and 9.77, and for desvenlafaxine it was 17.5 and 8.5 respectively. The mean HIT-6 scores at day 0 and at 3 months for the propranolol group were 54.52 and 41.60; for theamitriptyline group it was 52.85 and 45.33, for divalproex it was 53.2 and 44.71, and for desvenlafaxine it was 52.18 and 42.26 respectively. All the 4 groups had comparable reduction in headache burden and number of headache days permonth based on mean MIDAS and HIT-6 scores. Conclusion: All the 4 groups had comparable reduction in headache burden and number of headache days per month based on mean MIDAS and HIT-6 scores and on t-test there was no significant difference in the mean scores between the groups indicating similar efficacy of the drugs used in the study. There were no adverse or side effects noted in any of the patients. [ABSTRACT FROM AUTHOR]

Abstract Background Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headache frequency, medication intake, quality of life, disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. Methods In this Phase-III single-blind RCT carried out in a specialty Italian headache center, 177 patients with CM and MOH were randomized 1:1 to either TaU (withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis) or mindfulness-based intervention added to TaU (TaU + MIND). The mindfulness-based intervention consisted of six group session of mindfulness practice and 7–10 min daily self-practice. The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared to baseline, and was analyzed on an intention-to-treat principle using Pearson’s Chi-Squared test. Secondary endpoints included medication intake, quality of life (QoL), disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. The secondary endpoints were analyzed using per-protocol linear mixed models. Results Out of the 177 participants 89 were randomized to TaU and 88 to TaU + MIND. Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p

Abstract Aims The evidence supporting the efficacy of dietary preventive therapy in migraine is rising, particularly regarding the ketogenic diet. However, less evidence exists for the Low-Glycemic Index Diet and the 2:1 KD. This retrospective single-center real-life study aims to evaluate the efficacy of a 2:1 ketogenic diet and a Low-Glycemic-index Diet in chronic and high-frequency episodic migraine. Methods Sixty patients with high-frequency episodic and chronic migraine were treated with either a Low-Glycemic-index diet (39 patients) or a 2:1 (21 patients) ketogenic diet for three months. We collected data on the migraine frequency and intensity and the MIDAS and HIT-6 scores through the headache diary. Anthropometric measurements (BMI, fat mass, free fat mass, and weight) were also collected and analyzed similarly. Data obtained at the baseline and after three months of each diet were compared. Results Migraine intensity, frequency, MIDAS and HIT-6 scores, fat mass, weight, and BMI improved in both diet groups. Conclusions Both diets are effective in reducing migraine symptoms and migraine-related disability.

Aims: The evidence supporting the efficacy of dietary preventive therapy in migraine is rising, particularly regarding the ketogenic diet. However, less evidence exists for the Low-Glycemic Index Diet and the 2:1 KD. This retrospective single-center real-life study aims to evaluate the efficacy of a 2:1 ketogenic diet and a Low-Glycemic-index Diet in chronic and high-frequency episodic migraine. Methods: Sixty patients with high-frequency episodic and chronic migraine were treated with either a Low-Glycemic-index diet (39 patients) or a 2:1 (21 patients) ketogenic diet for three months. We collected data on the migraine frequency and intensity and the MIDAS and HIT-6 scores through the headache diary. Anthropometric measurements (BMI, fat mass, free fat mass, and weight) were also collected and analyzed similarly. Data obtained at the baseline and after three months of each diet were compared. Results: Migraine intensity, frequency, MIDAS and HIT-6 scores, fat mass, weight, and BMI improved in both diet groups. Conclusions: Both diets are effective in reducing migraine symptoms and migraine-related disability. [ABSTRACT FROM AUTHOR]

Background: Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headache frequency, medication intake, quality of life, disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. Methods: In this Phase-III single-blind RCT carried out in a specialty Italian headache center, 177 patients with CM and MOH were randomized 1:1 to either TaU (withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis) or mindfulness-based intervention added to TaU (TaU + MIND). The mindfulness-based intervention consisted of six group session of mindfulness practice and 7–10 min daily self-practice. The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared to baseline, and was analyzed on an intention-to-treat principle using Pearson's Chi-Squared test. Secondary endpoints included medication intake, quality of life (QoL), disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. The secondary endpoints were analyzed using per-protocol linear mixed models. Results: Out of the 177 participants 89 were randomized to TaU and 88 to TaU + MIND. Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p < 0.0001), and showed superior improvement in headache frequency, QoL and disability, headache impact, loss of productive time, medication intake, and in total, indirect and direct healthcare costs. Conclusions: A mindfulness-based treatment composed of six-week session and 7–10 min daily self-practice added on to TaU is superior to TaU alone for the treatment of patients with CM and MOH. Trial registration: MIND-CM was registered on clinicaltrials.gov (NCT03671681) on14/09/2018. [ABSTRACT FROM AUTHOR]

Abstract Background The German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therapeutics (DTx). The Digital Therapeutic sinCephalea is intended to act as a prophylactic treatment of migraine by reducing the migraine days. For this, sinCephalea determines personalized nutritional recommendations using continuous glucose monitoring (CGM) data and enables the patients to follow a personalized low-glycemic nutrition. Migraine is a headache disorder with the highest socioeconomic burden. Emerging evidence shows that CGM-based personalized nutritional recommendations are of prophylactic use in episodic migraine. However, prospective data are yet missing to demonstrate clinical effectiveness. This study is designed to fill this gap. Methods Patients between 18 and 65 years of age with proven migraine and a minimal disease severity of 3 migraine days per month are included. After a 4-week baseline phase as a pre-study, patients are randomized to the DTx intervention or a waiting-list control. The objective of the study is to show differences between the intervention and control groups regarding the change of migraine symptoms and of effects of migraine on daily life. Discussion To our knowledge, this is the first systematic clinical trial with a fully digital program to enable patients with migraine to follow a personalized low-glycemic nutrition in order to reduce their number of migraine days and the migraine-induced impact on daily life. Designing a clinical study using a digital intervention includes some obstacles, which are addressed in this study approach. Trial registration German Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021.

Acupuncture and fremanezumab are second-line treatments for migraine prophylaxis. We aimed to compare acupuncture with fremanezumab in the preventive treatment of episodic migraine by using a matching-adjusted indirect comparison analysis (MAIC). We acquired participant-level data from an acupuncture trial recruiting 302 participants and summary-level data from a fremanezumab trial recruiting 875 participants (290 participants received monthly fremanezumab [MF] and 291 received single-dose fremanezumab [SF]). The primary outcome was the mean reduction in monthly headache days. The secondary outcomes were the mean reduction in monthly moderate-to-severe headache days, days with acute medication, and the adverse events rate. Before matching, the acupuncture arm had significantly lower BMI, fewer headache days with at least moderate severity, and fewer days with acute medication. After matching, the baseline variables were comparable between groups. The three arms had no difference in the change of monthly migraine days (MF vs. acupuncture: mean difference 0.3, 95%CI −0.5 to 1.1, p-value = 0.473; SF vs. acupuncture: mean difference 0.5, 95%CI −0.3 to 1.3, p-value = 0.214). The results were similar in the analyses of secondary outcomes sensitivity analyses. Thirty-six (25%) participants in the acupuncture arm reported adverse events, versus 192(66%) participants in the MF arm and 193 (66%) in the SF arm. The preventive treatment effect of acupuncture is equivalent to fremanezumab, and it presented with a lower adverse event rate, which indicates that acupuncture can be an alternative to fremanezumab. [ABSTRACT FROM AUTHOR]

Objective: To examine the causal effect of potentially modifiable risk factors contributing to migraine pathogenesis. Methods: We performed Mendelian randomization analyses and acquired data from United Kingdom Biobank, FinnGen Biobank, and the MRC IEU OpenGWAS data infrastructure. An inverse-variance weighted (IVW) model was used to examine the relationship between 51 potentially modifiable risk factors and migraine in 3215 participants with migraine without aura (MwoA), 3541 participants with migraine with aura (MwA), and 176,107 controls. We adopted a Bonferronicorrected threshold of p = 9.8 × 10-4 (.05 divided by 51 exposures) as a sign of significant effect, and a p < .05 was considered as the sign of a suggestive association. Results: More years of schooling significantly correlated with lower odds of MwoA pathogenesis (OR .57 [95%CI .44 to .75], p < .0001). More vitamin B12 intake (OR .49 [95%CI .24 to .99], p = .046) and lower level of stress [OR 8.17 (95%CI 1.5 to 44.36), p = .015] or anxiety disorder (OR 1.92 × 109 [95%CI 8.76 to 4.23*1017], p = .029) were suggestive to be correlated lower odds of MwoA pathogenesis. More coffee intake (OR .39 [95%CI .22 to .7], p = .001), lower level of eicosapentaenoic acid status (OR 2.54 [95%CI 1.03 to 6.26], p = .043), and more light physical activity (OR .09 [95%CI .01 to .94], p = .046) were suggestive to be associated with lower odds of MwA. Conclusion: The years of schooling, light physical activity, vitamin B12 intake, and coffee intake were the protective factors for migraine; stress, anxiety, and eicosapentaenoic acid status were harmful factors. Interventions could be developed based on modifying these factors for migraine prophylaxis. [ABSTRACT FROM AUTHOR]

Guidelines regarding long-term use with onabotulinumtoxinA (onaBT-A) in chronic migraine (CM) prophylaxis are lacking. This multicentric prospective real-life study aimed to assess the efficacy and safety of a long-term treatment. A total of 195 chronic migraine patients were treated with onaBT-A, every 3 months for 5 cycles (Phase 1). In the Phase 2 of the study, depending on response rate, patients were divided into "responders" (R), "partially responders" (PR) and "non-responders" (NR). Then, we proposed to R and PR patients to continue with an additional 12 months of treatment (additional 4 sessions). Response to treatment and adverse events were collected for the entire duration of the study. Of the 195 patients included (females 82.1%, mean age 47.4 ± 12.4), at the end of Phase 1 there were 52.3% of R patients, 17.9% of PR patients, 15.4% of NR patients and 14.4% drop-outs. During Phase 2 of treatment, R patients presented a maintenance of the improvement achieved during the first year of treatment, as well as PR patients. Except for three serious adverse events not related to treatment, all other adverse events were mild or moderate in severity and resolved without sequelae. In the literature, adherence to oral migraine-preventive medications among patients with CM was found to be less than 25%. The results of this prospective real-life multicenter study show efficacy, safety and adherence to a long-term treatment with onaBT-A. [ABSTRACT FROM AUTHOR]

Background: The German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therapeutics (DTx). The Digital Therapeutic sinCephalea is intended to act as a prophylactic treatment of migraine by reducing the migraine days. For this, sinCephalea determines personalized nutritional recommendations using continuous glucose monitoring (CGM) data and enables the patients to follow a personalized low-glycemic nutrition. Migraine is a headache disorder with the highest socioeconomic burden. Emerging evidence shows that CGM-based personalized nutritional recommendations are of prophylactic use in episodic migraine. However, prospective data are yet missing to demonstrate clinical effectiveness. This study is designed to fill this gap. Methods: Patients between 18 and 65 years of age with proven migraine and a minimal disease severity of 3 migraine days per month are included. After a 4-week baseline phase as a pre-study, patients are randomized to the DTx intervention or a waiting-list control. The objective of the study is to show differences between the intervention and control groups regarding the change of migraine symptoms and of effects of migraine on daily life. Discussion: To our knowledge, this is the first systematic clinical trial with a fully digital program to enable patients with migraine to follow a personalized low-glycemic nutrition in order to reduce their number of migraine days and the migraine-induced impact on daily life. Designing a clinical study using a digital intervention includes some obstacles, which are addressed in this study approach. Trial registration: German Registry of Clinical Studies (Deutsches Register Klinischer Studien) DRKS-ID DRKS00024657. Registered on March 8, 2021. [ABSTRACT FROM AUTHOR]

Two million people in the Netherlands regularly experience migraine. In addition to preventive medication, a large proportion of patients also use drugs for the acute treatment of a migraine attack. The cornerstone of this therapy are the triptans, as well as paracetamol and NSAIDs. However, these drugs do not work well for all patients, or have adverse effects, and sometimes they are contraindicated. A new drug with a different mode of action could then bring relief. Rimegepant is the first of the ‘gepant’-type drugs to be authorised in the Netherlands. It belongs to the category of ‘calcitonin gene-related peptide’ (CGRP) antagonists. The question is whether rimegepant represents a useful addition to the conventional drugs for the acute treatment of migraine which are recommended in the guidelines. [ABSTRACT FROM AUTHOR]

Migraine is a headache disorder associated with a high socioeconomic burden. The digital therapeutic sinCephalea provides an individualized low-glycemic diet based on continuous glucose measurement and is intended to provide a non-pharmacological migraine prophylaxis. We performed two prospective studies with migraine patients who used sinCephalea over a period of 16 weeks. The patients used a headache diary and recorded their migraine-related daily life impairments using the assessment tools HIT-6 and MIDAS for a pre versus post comparison. In addition, continuous glucose data of patients were compared to healthy controls. In both studies, patients reported a reduction of headache and migraine days as well as reductions in HIT-6 and MIDAS scores. More specifically, migraine days decreased by 2.40 days (95% CI [−3.37; −1.42]), HIT-6 improved by 3.17 points (95% CI [−4.63; −1.70]) and MIDAS by 13.45 points (95% CI [−22.01; −4.89]). Glucose data suggest that migraine patients have slightly increased mean glucose values compared to healthy controls, but drop into a glucose range that is below one's individual standard range before a migraine attack. In conclusion, sinCephalea is a non-pharmacological, digital migraine prophylaxis that induces a therapeutic effect within the range of pharmacological interventions. [ABSTRACT FROM AUTHOR]

Background: Migraine headache are usually characterized by pain on one or both sides of the head1. Migraine headaches are often accompanied by photophobia, phonophobia and vomiting. Pharmacological treatment is traditionally divided into acute or symptomatic treatment, and preventive treatment or prophylaxis. Most studies have evaluated the efficacy of such drugs alone; however, there are some studies with propranolol and tricyclic agents in association with other drugs. The clinical experience with combination therapy for migraine seems to be a rational approach when monotherapy fails and when migraine is refractory. Several drugs are used individually for migraine prophylaxis. Objective: The purpose of the present study was to compare the propranolol and amitriptyline as monotherapy for the prophylaxis of migraine. Materials and methods: This is a prospective, double-blinded, randomized, comparative, with a parallel group design and single center study conducted at Department of General Medicine at Surabhi Institute of Medical Sciences. Patients between 18 and 70 years of age, of either sex (male/female) with a diagnosis of Migraine either with or without aura as per The International Classification of Headache Disorders (ICHD) criteria were recruited in the study. Patients had more than two attacks of headache per month, each episode lasting for more than 2 days > 2 episodes/months. Result: In both the groups, maximum number of patients were in the age group of 5-25 years and least number of patients were 46-65 years of age. Mean age in group 1 patients were 29.25±9.75 and in Group 2 patients were 30.05±9.71. There was no statistically significant difference in mean age of patient from Group 1 and Group 2 patients with unpaired t test. the mean severity of Attack of migraine in Group 1 at period 1 was 4.95 with SD of 1.88 and period 2 was 4.15 with SD 1.68. In Group 2 during period 1 was 4.05 with SD of 1.75 and in period 2 mean 4.81 with SD 1.85. These was statistically significant difference in Group 1 and Group 2 (p=0.028) with Unpaired t test. Conclusion: Migraine is one of the most common disabling conditions in the world, which undermines quality of life; the mean number of migraine attacks in the Amitriptyline and the Propranolol group decreased as the duration of treatment increased. [ABSTRACT FROM AUTHOR]

Background: Migraine is characterized by moderate to severe recurrent headache lasting for 4–72 h. Cortical hyperexcitability may play a crucial role in migraine onset. Therefore, antiepileptic drugs, such as levetiracetam, may be beneficial. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and prospective studies that evaluated the efficacy of levetiracetam in migraine prophylaxis. Electronic databases, including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, were searched for articles on migraine prophylaxis and levetiracetam published before May 2020. The main outcomes were number of patients with >50% headache frequency reduction, frequency of headache, and headache severity. Results: We identified 4 RCTs involving 192 patients and 4 prospective studies involving 85 patients. The overall data on number of patients with >50% headache frequency reduction, headache frequency, and headache severity were subjected to meta-analysis, which revealed significant differences between the levetiracetam and the placebo groups (risk ratio [RR] of number of patients with >50% headache frequency reduction = 0.46, 95% confidence interval [CI] = 0.35 to 0.61; weighted mean difference [WMD] of headache frequency per month = −3.78, 95% CI = −5.52 to −2.03; standard mean difference [SMD] of headache severity = −2.42, 95% CI = −4.47 to −0.37). Conclusion: Our study indicated that levetiracetam can significantly reduce headache frequency and severity in adults and children. Thus, oral levetiracetam can be a therapeutic option for migraine prophylaxis, especially concerning with the adverse effects or teratogenicity of other preventive treatments.

Aim: Evaluate the efficacy and safety of non-invasive vagus nerve stimulation for migraine prevention. Methods: After completing a 4-week diary run-in period, adults who had migraine with or without aura were randomly assigned to receive active non-invasive vagus nerve stimulation or sham therapy during a 12-week double-blind period. Results: Of 336 enrolled participants, 113 (active, n = 56; sham, n = 57) completed ≥70 days of the double-blind period and were ≥66% adherent with treatment, comprising the prespecified modified intention-to-treat population. The COVID-19 pandemic led to early trial termination, and the population was ∼60% smaller than the statistical target for full power. Mean reduction in monthly migraine days (primary endpoint) was 3.12 for the active group and 2.29 days for the sham group (difference, −0.83; p = 0.2329). Responder rate (i.e. the percentage of participants with a ≥50% reduction in migraine days) was greater in the active group (44.87%) than the sham group (26.81%; p = 0.0481). Prespecified subgroup analysis suggested that participants with aura responded preferentially. No serious device-related adverse events were reported. Conclusions: These results suggest clinical utility of non-invasive vagus nerve stimulation for migraine prevention, particularly for patients who have migraine with aura, and reinforce the well-established safety and tolerability profile of this therapy. Trial Registration: ClinicalTrials.gov (NCT03716505). [ABSTRACT FROM AUTHOR]

The availability and use of melatonin as an over-the-counter supplement have surged significantly in recent years due to the increased prevalence of sleep-wake disorders, notably in the post-COVID-19 era. While melatonin is known for managing insomnia, its applications extend beyond that. Its anti-inflammatory, antioxidant, and analgesic properties, along with increased usage, have garnered significant interest from researchers, particularly regarding its use in migraine prophylaxis and treatment. The aim of this systematic review is to evaluate the role of melatonin as prophylactic therapy for migraine, focusing on the efficacy and side effect profile of melatonin compared to standard therapy and placebo. Six databases were searched through June 2024, identifying 735 relevant articles. Only full-text randomized control trials involving humans, written or translated into English, were included in the study. Data were extracted, screened, sought for retrieval, and assessed for quality appraisal using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). A total of seven randomized control trials involving 1,283 participants who met the eligibility criteria and passed the quality appraisal have been included in the study. All seven trials included patients diagnosed with migraine who were treated with either melatonin or agomelatine and were compared to those treated with conventional prophylactic therapy or placebo. The findings of this review suggest that melatonin significantly reduces the frequency and severity of migraines, but its dose-dependent action and benefits remain debatable. Melatonin may also have a role in weight control, warranting additional research in this direction., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Nelakuditi et al.)

Introduction: This study was conducted to provide detailed information about clinical characteristics and short-term treatment outcome of childhood headache. Materials and Methods: This prospective observational study was done over a period of 15 months (January 2013 to March 2014) at a rural tertiary care center in North India. Detailed history, clinical examination, specialty review, and follow-up details were maintained on pretested structured proforma. Final diagnosis of headache type was made as per International Classification of Headache Disorders, 2nd edition. Results: Out of 100 (45 boys) children aged 8–18 years, 52% were diagnosed with migraine, 23% with tension-type headache, and 25% with secondary headache. Diffuse headache was the commonest (41%), and photophobia, phonophobia, and dizziness were the commonest symptoms in all headache subtypes. Sixty-five percentage of migraine headache were triggered by exertion. Lack of sleep and anxiety were triggers in most (65%) of tension type headache. Of 52 migraine children, 21 were started on prophylaxis for migraine and 14 of them reported significant improvement. Secondary causes for headache were found in 25% of children and half of them were having refractive errors. Conclusions: Results of the study show migraine being the commonest type of headache in children followed by secondary headache. This study also highlights the need for long-term follow-up of childhood headache. [ABSTRACT FROM AUTHOR]

During a 1-year compassionate use program, 156 patients with migraine self-administered a monthly dose of erenumab 140 mg with a subcutaneous autoinjector. Main inclusion criteria were: ≥ 4 migraine days/month and ≥two prior prophylactic treatment failures. The patients covered the migraine severity spectrum from episodic migraine (EM) (n = 80) to chronic migraine (CM) (n = 76). During the 3rd month of treatment, monthly headache days decreased by 45.7% in EM and 35.5% in CM. The 50% responder rate for reduction in monthly headache days was significantly higher in EM (55%) than in CM (43%) (p = 0.05). In both the migraine subgroups, the clinical improvement vs. baseline was already significant during the 1st month of treatment (p < 0.001). There were also significant reductions in mean headache severity, duration, and monthly days with acute drug intake. The 30% responder rate at 3 months was 60% in CM and 54.1% of patients reversed from CM to EM. The therapeutic effect was maintained at 12 months when 50% responder rates, considering discontinuation for lack of efficacy or adverse effects as 0% response, still were 51% in EM and 41% in CM. A total of 10 patients with EM (12.5%) and 23 patients with CM (30.3%) had discontinued treatment, considering the treatment as ineffective. At 3 months, 48% of patients reported non-serious adverse events among which the most frequent was constipation (20.5%); corresponding figures at 12 months were 30 and 15%. Discontinuation due to an adverse effect for the entire 12 month period was rare (3.8%). The lower efficacy in CM than in EM was mainly due to a very low 50% responder rate in patients with CM with continuous pain (13%) as compared to CM with pain-free periods (58%) (p < 0.001). Similarly, the 50% responder rate was lower in patients with ≥two prior prophylactic treatment failures (40.5%) compared to those with two failures (70%) (p < 0.05). There was no significant efficacy difference between low (4–7 migraine days/month, n = 22) and high frequency (8–14 days, n = 59) EM nor between patients with CM with (n = 50) or without (n = 26) acute medication overuse. Erenumab had no effect on the frequency of auras. Taken together, erenumab 140 mg monthly was highly effective for migraine prophylaxis over the whole severity spectrum of the disease, except in patients with continuous headaches. Its effect is significant after the first injection, quasi-maximal after the second injection, and does not wear off after 12 months. The most frequent adverse effect was constipation. These results are compared to those published for erenumab in the pivotal randomized placebo-controlled trials and to those reported in several recent real-world studies.

During a 1-year compassionate use program, 156 patients with migraine self-administered a monthly dose of erenumab 140 mg with a subcutaneous autoinjector. Main inclusion criteria were: ≥ 4 migraine days/month and ≥two prior prophylactic treatment failures. The patients covered the migraine severity spectrum from episodic migraine (EM) (n = 80) to chronic migraine (CM) (n = 76). During the 3rd month of treatment, monthly headache days decreased by 45.7% in EM and 35.5% in CM. The 50% responder rate for reduction in monthly headache days was significantly higher in EM (55%) than in CM (43%) (p = 0.05). In both the migraine subgroups, the clinical improvement vs. baseline was already significant during the 1st month of treatment (p < 0.001). There were also significant reductions in mean headache severity, duration, and monthly days with acute drug intake. The 30% responder rate at 3 months was 60% in CM and 54.1% of patients reversed from CM to EM. The therapeutic effect was maintained at 12 months when 50% responder rates, considering discontinuation for lack of efficacy or adverse effects as 0% response, still were 51% in EM and 41% in CM. A total of 10 patients with EM (12.5%) and 23 patients with CM (30.3%) had discontinued treatment, considering the treatment as ineffective. At 3 months, 48% of patients reported non-serious adverse events among which the most frequent was constipation (20.5%); corresponding figures at 12 months were 30 and 15%. Discontinuation due to an adverse effect for the entire 12 month period was rare (3.8%). The lower efficacy in CM than in EM was mainly due to a very low 50% responder rate in patients with CM with continuous pain (13%) as compared to CM with pain-free periods (58%) (p < 0.001). Similarly, the 50% responder rate was lower in patients with ≥two prior prophylactic treatment failures (40.5%) compared to those with two failures (70%) (p < 0.05). There was no significant efficacy difference between low (4–7 migraine days/month, n = 22) and high frequency (8–14 days, n = 59) EM nor between patients with CM with (n = 50) or without (n = 26) acute medication overuse. Erenumab had no effect on the frequency of auras. Taken together, erenumab 140 mg monthly was highly effective for migraine prophylaxis over the whole severity spectrum of the disease, except in patients with continuous headaches. Its effect is significant after the first injection, quasi-maximal after the second injection, and does not wear off after 12 months. The most frequent adverse effect was constipation. These results are compared to those published for erenumab in the pivotal randomized placebo-controlled trials and to those reported in several recent real-world studies. [ABSTRACT FROM AUTHOR]

Background: Acupuncture is commonly used for migraine prophylaxis; however, evidence of its efficacy was equivocal. Aim: We aimed to evaluated the efficacy of acupuncture in migraine prophylaxis and calculated the required information size (RIS) to determine whether further clinical studies are required. Methods: We searched Cochrane library, EMBASE and PubMed from inception to April 23th, 2020. Randomized trials that compared acupuncture with conventional drug therapy or sham acupuncture were included. The primary outcome was migraine episodes. Secondary outcomes were responder rate and adverse event. Results: Twenty studies (n = 3380) met the inclusion criteria. When it comes to migraine episodes, Acupuncture was superior over sham acupuncture [SMD = − 0.29, 95% CI (− 0.47 to − 0.11), P = 0.002] after treatment, while the difference between acupuncture and prophylactic drugs was not significant [SMD = − 0.21, 95% CI (− 0.42 to 0.00), P = 0.06].Both TSA graphs indicated that more RCTs are needed. As for responder rate, the results after treatment showed that acupuncture was statistically significantly better than sham acupuncture [RR 1.30, 95% CI (1.09–1.55), P = 0.003] as well as conventional drugs [RR 1.24, 95% CI (1.04–1.48), P = 0.01]. Both of their cumulative Z-curves intersected with the trial sequential monitoring boundaries favoring acupuncture. Compared to prophylactic medication, acupuncture can cause less adverse events [RR 0.34, 95% CI (0.14–0.81), P = 0.01]. Conclusion: Acupuncture can reduce migraine episodes compared to sham one and can be an alternative and safe prophylactic treatment for conventional drugs therapy, but it should be further verified through more RCTs. Available studies suggested acupuncture was superior to sham acupuncture and conventional drugs in terms of responder rate as verified by TSA. [ABSTRACT FROM AUTHOR]

Purpose: Calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are new agents approved by the US Food and Drug Administration for preventive treatment of chronic migraine. Comparison between CGRPmAbs and previously approved Botulinum neurotoxin A (BoNT-A) will inform optimal preventive treatment of chronic migraine, but head-to-head trials are lacking. We therefore aimed to perform adjusted indirect comparison between CGRPmAbs and BoNT-A through a meta-analysis.Methods: OVID MEDLINE, EMBASE and the Cochrane central register of controlled trials, clinical registries, and government websites were searched from inception to September 2019. Randomized controlled trials comparing CGRPmAbs or BoNT-A with placebo in the preventive treatment of chronic migraine were included. The primary outcomes were headache days and migraine days measured at week 12. Data were synthesized by using a frequentist approach; and the treatments were ranked by P-score.Results: We included 10 trials (n = 4,678) after screening 1049 candidates. Six trials were with low risk of bias. Fremanezumab had an effect similar to BoNT-A in the reduction of headache days at week 12 (standard mean difference [SMD] 0.08, 95%CI -0.55 to -0.7). Galcanezumab reduced more migraine days than BoNT-A at week 12 (SMD, -0.94, 95%CI −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%CI −0.85 to −0.24). Galcanezumab and fremanezumab had better effect in mitigating headache impact at week 12. CGRPmAbs and BoNT-A had similar adverse event rate.Conclusion: CGRPmAbs and BoNT-A had similar effect in the preventive treatment of chronic migraine. BoNT-A might be preferentially selected owing to its cost-effectiveness profiles. Further studies with direct comparison of the two treatments are warranted.

Objectives: Transcranial direct current stimulation (tDCS) has been suggested as an alternative treatment option for migraine. The present study aimed to evaluate the efficacy of tDCS on clinical outcomes in addition to calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating peptide 38 (PACAP-38) levels in individuals with menstrual-related migraine (MRM) for the first time., Materials and Methods: In this parallel study, 58 female patients between the ages of 18 and 45 years, including 36 with MRM and 22 with nonmenstrual migraines (nMM), were recruited. Sessions of 2-mA 20-minute anodal tDCS were administered over the left dorsolateral prefrontal cortex within three consecutive days (1:1 active and sham stimulation). Migraine attack frequency, severity, analgesic usage, CGRP, and PACAP-38 levels of the patients were evaluated before and one month after tDCS., Results: After tDCS, in the active group compared with the sham group, the frequency (p = 0.031), the severity of attacks (p = 0.003), the number of days with headache (p = 0.004), and the analgesic usage (p = 0.024) were all decreased. In both MRM and nMM groups, the frequency and severity of attacks and analgesic usage were decreased in those receiving active stimulation (p < 0.001 for each). CGRP and PACAP-38 levels were no different in the active group and the sham group after tDCS., Conclusions: tDCS was shown to be efficacious in migraine prophylaxis and a valuable option for migraine and MRM treatment. The absence of changes in serum CGRP and PACAP-38 levels suggests that tDCS efficacy may stem from distinct cerebral electrophysiological mechanisms., Competing Interests: Conflict of Interest The authors report no conflict of interest., (Copyright © 2024 International Neuromodulation Society. All rights reserved.)

Abstract Migraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines. Previous (2014) European recommendations on limiting the use of valproate in women of childbearing age did not achieve their objective in terms of limiting the use of valproate in women of childbearing age and raising awareness regarding the hazardous effect of valproate to children exposed in utero. The teratogenic and foetotoxic effects of valproate are well documented, and more recent studies show that there is an even greater neurodevelopmental risk to children exposed to valproate in the womb. The latest 2018 European review from the European Medicines Agency, with the active participation of the European Headache Federation, concluded that not enough has been done to mitigate the risks associated with in utero exposure to valproate. The review called for more extensive restrictions to the conditions for prescribing, better public awareness, and a more effective education campaign in migrainous women.

Migraine is an unpleasant neurological disorder characterized by frequent severe headache attacks associated with nausea, phonophobia, or photophobia with or without aura. Preventive treatment is an essential part of migraine management if it is indicated in certain circumstances. β-blockers are widely used for reducing migraine attacks frequency and severity for a long time with favorable adverse effects profile. The prevalence of migraine is approximately 12% in the general adult population, and 18% in women, 6% in men in the US population-based studies. Almost 90% of migrainous patients experience moderate or severe pain, three quarter have reduced functional capacity during attacks of headache, and one-third require bed rest during the attacks with performing daily chores, and maintain active family, the inability to work, social, and community relationships. This literature review summarizes the principles of migraine preventive therapy, particularly the efficacy of β-blockers. We did a search in the PubMed database looking for relevant articles on the topic. We used MeSh words: β-blockers, β-adrenergic antagonist, Migraine, and Migraine prevention. β-blockers are highly effective in migraine prevention and provide different classes with a preferable safety profile. [ABSTRACT FROM AUTHOR]

Background: Migraine is characterized by moderate to severe recurrent headache lasting for 4-72 h. Cortical hyperexcitability may play a crucial role in migraine onset. Therefore, antiepileptic drugs, such as levetiracetam, may be beneficial.Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and prospective studies that evaluated the efficacy of levetiracetam in migraine prophylaxis. Electronic databases, including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, were searched for articles on migraine prophylaxis and levetiracetam published before May 2020. The main outcomes were number of patients with >50% headache frequency reduction, frequency of headache, and headache severity.Results: We identified 4 RCTs involving 192 patients and 4 prospective studies involving 85 patients. The overall data on number of patients with >50% headache frequency reduction, headache frequency, and headache severity were subjected to meta-analysis, which revealed significant differences between the levetiracetam and the placebo groups (risk ratio [RR] of number of patients with >50% headache frequency reduction = 0.46, 95% confidence interval [CI] = 0.35 to 0.61; weighted mean difference [WMD] of headache frequency per month = -3.78, 95% CI = -5.52 to -2.03; standard mean difference [SMD] of headache severity = -2.42, 95% CI = -4.47 to -0.37).Conclusion: Our study indicated that levetiracetam can significantly reduce headache frequency and severity in adults and children. Thus, oral levetiracetam can be a therapeutic option for migraine prophylaxis, especially concerning with the adverse effects or teratogenicity of other preventive treatments. [ABSTRACT FROM AUTHOR]

Objective: To determine reversion rates from chronic migraine to episodic migraine during long-term erenumab treatment. Methods: A daily headache diary was completed during the 12-week, double-blind treatment phase of a placebo-controlled trial comparing erenumab 70 mg, 140 mg, and placebo, and weeks 1–12, 21–24, 37–40, and 49–52 of the open-label treatment phase. Chronic migraine to episodic migraine reversion rates were assessed over the double-blind treatment phase; persistent reversion to episodic migraine over 24 weeks (double-blind treatment phase through the first 12 weeks in the open-label treatment phase), long-term persistent reversion to episodic migraine over 64 weeks (double-blind treatment phase plus open-label treatment phase); delayed reversion to episodic migraine through the first 12 weeks of the open-label treatment phase among patients remaining in chronic migraine during the double-blind treatment phase. Results: In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8–58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg. Among 181 completers (receiving erenumab for 64 weeks), 98 (54.1% [95% confidence interval: 46.6–61.6]) had reversion to episodic migraine during the double-blind treatment phase; of those, 96.9% (95% confidence interval: 91.3–99.4) had persistent reversion to episodic migraine, 96.8% (95% confidence interval: 91.1–99.3) of whom had long-term persistent reversion to episodic migraine. Delayed reversion to episodic migraine occurred in 36/83 (43.4% [95% confidence interval: 32.5–54.7]) patients; of these, 77.8% (95% confidence interval: 60.9–89.9) persisted in reversion through week 64. Conclusions: Patients with reversion to episodic migraine at week 12 will likely persist as episodic migraine with longer-term erenumab; others may achieve delayed reversion to episodic migraine. Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02066415 [ABSTRACT FROM AUTHOR]

This study aimed to describe the demographic and clinical characteristics of migraineurs prescribed ≥1 migraine prophylactic therapy, and to analyze their therapeutic pathways, healthcare resource consumption, and related costs. This retrospective analysis was based on administrative databases from two regions and three local health units in Italy. Adult patients with ≥1 discharge diagnosis for migraine or ≥1 prescription for migraine-specific drugs, or ≥1 emergency room visit for migraine from 1 January 2010 to 31 December 2016 were included if they had received ≥1 migraine prophylactic therapy between 1 January 2011 and 31 December 2015 (enrollment period). The first date of the last migraine prophylactic treatment was considered as the index date (ID). Patients were characterized 1-year prior ID and followed-up for 1 year afterwards. Of the 166,362 identified migraineurs, 32,794 (mean age: 45.9 ± 13.9 years, 19.2% male) who received migraine prophylaxis were included in the analysis. At ID, 31,629 patients had received 1 prophylactic treatment with antidepressants (51.2%), neuromodulators (28.1%), beta blockers (12.4%), other migraine preparations (7.8%), and botulinum toxin A (0.5%). Focusing on patients with one prophylactic treatment at ID, 85.4% did not have any previous therapeutic failures whereas 14.6% had ≥1 previous failure. During follow-up, 5% of patients made a therapeutic switch after a mean period of 103.4 ± 97.9 days. Total mean annual cost for patients receiving migraine prophylaxis was 1193.64€ during characterization and 1303.86€ during follow-up periods. This real-world study gave insights on the characterization of migraineurs and patterns of prophylaxis utilization in Italian clinical settings, showing an underuse of prophylactic agents. [ABSTRACT FROM AUTHOR]

OnabotulinumtoxinA (OBT-A) and monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway are two of the few treatments that ameliorate chronic migraine (CM) in randomized controlled trials and real-life studies. Separate clinical practice guidelines have been developed for the management of CM with OBT-A or CGRP-targeting mAbs. Considering the concomitant availability of OBT-A and CGRP-targeting mAbs as therapeutic treatment options, Italian migraine experts reviewed the evidence supporting the efficacy of OBT-A and CGRP-targeting mAbs in CM in order to rationalize the management of CM patients treated with OBT-A. Experts addressed everyday practice needs to shape the optimal pharmacological management by balancing adherence to regulatory indications, ethical considerations, and clinical expertise. Considering the remarkable challenge of improving the health and quality of life of patients with CM, even partial improvements may be clinically meaningful, particularly for those who are resistant or intolerant to oral migraine treatments. In this collaborative effort, we propose a treatment algorithm that integrates the relevant aspects of managing patients with CM to provide ready-to-use practical guidance regarding the appropriate use of OBT-A. [ABSTRACT FROM AUTHOR]

Background: Migraine clinical profile may change with age, making it necessary to verify that migraine treatments are equally safe and effective in older patients. These analyses evaluated the effects of patient age on the pharmacokinetics (PK), efficacy, and safety of galcanezumab for prevention of migraine. Methods: Analyses included efficacy data from three double-blind phase 3 clinical trials: two 6-month studies in episodic migraine (EVOLVE-1, EVOLVE-2: N = 1773) and one 3-month study in chronic migraine (REGAIN:N = 1113). Patients were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. Safety and PK data included additional phase 2 and phase 3 trials for a larger sample size of patients > 60 years (range = 18–65 for all studies). Subgroup analyses assessed efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes by patient age group. Galcanezumab PK were evaluated using a population analysis approach, where age was examined as a potential covariate on apparent clearance (CL/F) and apparent volume of distribution (V/F) of galcanezumab. Results: Numbers of baseline monthly migraine headache days were similar across age groups. There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use. Age (18–65) had a minimal effect on CL/F, and no effect on V/F. Galcanezumab-treated patients ≥60 years experienced no clinically meaningful increases in blood pressure and no increased frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs, compared to age-matched placebo-treated patients. Conclusions: Age (up to 65 years) does not affect efficacy in migraine prevention and has no clinically meaningful influence on galcanezumab PK to warrant dose adjustment. Furthermore, older galcanezumab-treated patients experienced no increases in frequency of AEs or increases in blood pressure compared with age-matched placebo-treated patients. Trial registrations: EVOLVE-1 (NCT02614183, registered 23 November 2015), EVOLVE-2 (NCT02614196, 23 November 2015), REGAIN (NCT02614261, 23 November 2015), ART-01 (NCT01625988, 20 June 2012,), I5Q-MC-CGAB (NCT02163993, 12 June 2014,), I5Q-MC-CGAJ (NCT02614287, 23 November 2015,), all retrospectively registered. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Many parallel-group studies of migraine prophylaxis using valproate medications were reported in recent decades. This meta-analysis assessed the efficacy and safety of valproate medications for migraine prophylaxis in adults. MATERIALS AND METHODS: Searches were conducted in five databases: PubMed, Wiley, ScienceDirect, Web of Science, and the Cochrane Library. The data were acquired through December 31, 2018. Two independent authors searched for controlled clinical trials involving the use of valproate medications in migraine prophylaxis. Studies that met the inclusion criteria were assessed, and their methodological quality was examined. RESULTS: Seven placebo-controlled studies (782 participants) and seven controlled trials against active comparators (554 participants) were included in the final analysis. The active treatment of valproate medications was significantly superior to placebo (OR, 4.02; 95% CI 2.17-7.44; I2 = 66%). Compared with the other active comparators, there were no significant differences between treatments in the proportion of responders. CONCLUSIONS: Valproate medications were more effective than placebo in migraine prevention, with statistically significant differences. Both valproate and the other active comparators were well-tolerated, and no significant difference was noted in efficacy and safety for the prophylaxis of migraine. [ABSTRACT FROM AUTHOR]

Abstract Background Chronic migraine is a complex clinical condition often undertreated. Onabotulinumtoxin A (OBT-A) was approved in Italy in 2013 for symptom relief in patients with chronic migraine who have failed, or do not tolerate, oral prophylactic treatments. However, the impact of OBT-A in clinical practice remains to be defined. Methods To investigate the current management of chronic migraine with OBT-A in clinical practice, a web-based survey was conducted among clinicians working in third-level headache centers across Italy. A 26-item questionnaire was designed and developed by a group of 10 Italian headache specialists to address the following issues: treatment paradigm and OBT-A injection intervals, frequency of treatment and retreatment, definition of responders/non-responders, satisfaction with treatment potential impact of early treatment with OBT-A. Ninety-six headache centers were selected and contacted via e-mail. The online survey was anonymous and carried out using a secure website. Results Overall, 64 of the 96 centers (66.7%) completed the questionnaire. Most centers (98.4%) had been using OBT-A for >1 year. OBT-A was administered according to the PREEMPT paradigm in most centers (88.9%). While during the first year of prophylaxis with OBT-A most clinicians (93.6%) repeated OBT-A treatment every 3 months, as recommended, in the following years interval duration was variable. Response to OBT-A was defined as a ≥ 50% reduction in the headache days by 58.7% of the clinicians, and as a ≥ 30% reduction by 25.4% of them. Almost 60% of the clinicians considered OBT-A as a long-lasting therapy, while for one-third of them treatment could be discontinued in patients showing a benefit for ≥6 months. According to 80% of the clinicians, early administration of OBT-A after the onset of chronic migraine was associated with better outcomes, and 47.6% felt that OBT-A should be recommended as a first-line option. Conclusions This survey indicates that in third-level headache centers in Italy OBT-A is used in good compliance with current recommendations. There is agreement about the definition of response as a reduction in headache days by 30% to 50%. Additional effort is required to define response to OBT-A and to establish optimal treatment duration.

The article aims to explore the challenges involved in diagnosing and managing Alice in Wonderland Syndrome (AIWS) in pediatric cases, focusing on an eight-year-old female with perceptual distortions affecting vision, hearing, and time perception. AIWS, a rare neurological phenomenon, manifests as distortions in the perception of the body and external stimuli. The lack of established diagnostic criteria, particularly in the pediatric population, complicates accurate identification. The presented case illustrates visual anomalies, auditory abnormalities, and tachysensia, emphasizing the multisensory nature of AIWS. The temporal association with underlying causes, such as migraines and viral infections, highlights the need for a comprehensive evaluation. The Acharya Vinoba Bhave Rural Hospital management approach involves a systematic assessment, identification of underlying chronic conditions, and targeted treatment. Migraine prophylaxis, utilizing prescription drugs and a low-tyramine diet, plays a central role. The limited use of antipsychotics underscores the neurological origin of AIWS. The article contributes valuable insights into pediatric AIWS, advocating for further research and awareness. The article also aims to highlight the lack of established diagnostic criteria for AIWS, particularly in the pediatric population, and to present a systematic management approach based on a specific case study. The multidisciplinary collaboration, regular follow-ups, and patient education constitute a comprehensive approach to enhance understanding and alleviate symptoms in AIWS cases., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Manwar et al.)

Background: Migraines are a common comorbidity and source of disability in patients with chronic inflammatory diseases like multiple sclerosis (MS). Recently, therapeutic agents for episodic and chronic migraine known as calcitonin gene-related peptide (CGRP) inhibitors have shown to effectively control migraine attacks and improve quality of life in the general population. This study explored the use of these novel agents in individuals with comorbid MS., Methods: This was a retrospective, population-based cohort study at the University of South Florida's neurology clinic; it evaluated individuals with both MS and migraine., Results: A total of 27 individuals with MS and chronic or episodic migraine who received treatment with a CGRP monoclonal antibody were identified. Of these, 63% reported a reduction in their migraine frequency of greater than 75%. Concurrent use of a disease-modifying therapy (DMT) for MS occurred in 82% of patients, and in 37% of these, the DMT used was also a monoclonal antibody. Adverse effects from CGRP monoclonal antibodies were mild and occurred in only 11% of patients, and no patient experienced worsening of their MS symptoms during cotreatment over the duration of the study., Conclusions: Our study showed a significant reduction in migraine frequency and a favorable adverse event profile for individuals with comorbid MS who took CGRP monoclonal antibodies and experienced no worsening of MS symptoms. In individuals with MS, CGRP monoclonal antibodies seem to be a safe and effective therapy for episodic or chronic migraine., Competing Interests: PRIOR PRESENTATION: This data was previously presented at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting; June 2, 2022; National Harbor, Maryland., (© 2024 Consortium of Multiple Sclerosis Centers.)

Introduction: Most preventive migraine treatments modify the brain's excitation/inhibition balance and/or serotonin metabolism, which likely accounts for their unfavorable adverse effect profile. Novel biological therapies blocking CGRP transmission are effective and better tolerated, but they are expensive and may not influence brain dysfunctions upstream in the pathophysiological cascade of migraine, including premonitory and aura symptoms. Biochemical and clinical studies suggest that there may be another complimentary treatment strategy, the one that targets the underestimated metabolic facet of migraine pathophysiology. Areas covered: After a brief description of the metabolic abnormalities found in migraine patients, we will review and discuss published data on metabolic treatments of migraine. There is evidence that riboflavin and co-enzyme Q10 are effective for the prevention of migraine and quasi devoid of adverse effects. Response rates are close to those of topiramate, propranolol, and CGRP/CGRPrec mAbs. The evidence is weaker for thioctic acid. Dietary and pharmacological strategies inducing ketosis are novel promising approaches for which preliminary trials with favorable outcomes have been published. Expert opinion: Metabolic treatments of migraine constitute an effective, well-tolerated, inexpensive, and evidence-supported therapeutic option for migraine prophylaxis, and may be considered as first treatment line in many patients, including in children and adolescents. [ABSTRACT FROM AUTHOR]