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6. Headache and Eye Pain

Author

Digre, Kathleen B., Friedman, Deborah I., Levin, Leonard, Section editor, Cestari, Dean, Section editor, Albert, Daniel M., editor, Miller, Joan W., editor, Azar, Dimitri T., editor, and Young, Lucy H., editor

Published
2022
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7. Diagnosis and Treatment of Spontaneous Intracranial Hypotension

Author

Callen, Andrew L., primary, Friedman, Deborah I., additional, Parikh, Simy, additional, Rau, Jill C., additional, Schievink, Wouter I., additional, Cutsforth-Gregory, Jeremy K., additional, Amrhein, Timothy J., additional, Haight, Elena, additional, Cowan, Robert P., additional, Barad, Meredith J., additional, Hah, Jennifer M., additional, Jackson, Tracy, additional, Deline, Connie, additional, Buchanan, Andrea J., additional, and Carroll, Ian, additional

Published
2024
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9. Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post‐Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial

Author

Dodick, David W, Tepper, Stewart J, Friedman, Deborah I, Gelfand, Amy A, Kellerman, Donald J, and Schmidt, Peter C

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Neurosciences, Clinical Research, Chronic Pain, Clinical Trials and Supportive Activities, Headaches, Pain Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Biomarkers, Double-Blind Method, Humans, Hyperacusis, Injections, Intradermal, Migraine Disorders, Nausea, Outcome Assessment, Health Care, Oxazolidinones, Photophobia, Serotonin 5-HT1 Receptor Agonists, Tryptamines, migraine, headache, triptan, zolmitriptan, drug delivery, intracutaneous, adhesive dermally applied microarray, Neurology & Neurosurgery, Clinical sciences
Abstract

ObjectiveTo better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions.BackgroundAdhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain-free and MBS-free at 2 hours post-dose, was significantly higher than for placebo.MethodsWe undertook a post-hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co-primary endpoints of pain relief, nausea, photophobia, and phonophobia.ResultsOf the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), phonophobia (n = 43), and nausea (n = 37). Two-hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two-hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P

Published
2018

10. Migraine

Author

Friedman, Deborah I., Masrour, Shamin, and Noe, Carl Edward, editor

Published
2020
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18. Literature Commentary

Author

Moster, Mark L., Dinkin, Marc J., and Friedman, Deborah I.

Abstract

In this issue of JNO Drs. Mark L. Moster, Marc Dinkin, and Deborah I. Friedman discuss the following six articles.

Published
2024
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27. Supplemental Material - Brachial Artery Vasospasm From Sequential Use of Intravenous Promethazine and Dihydroergotamine for Treatment of Status Migrainosus: A Case Report

Author

Johns, Christopher, Ardakani, Rumyar, Das, Rohit R., Friedman, Deborah I., and Frolov, Alexander

Subjects
FOS: Clinical medicine, 110306 Endocrinology, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental Material for Brachial Artery Vasospasm From Sequential Use of Intravenous Promethazine and Dihydroergotamine for Treatment of Status Migrainosus: A Case Report by Christopher Johns, Rumyar Ardakani, Rohit R. Das, Deborah I. Friedman, and Alexander Frolov in The Neurohospitalist.

Published
2023
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30. Headache

Author

Friedman, Deborah I., additional, Masrour, Shamin, additional, and Hutchinson, Susan, additional

Published
2018
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