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3. Add-on cannabidiol treatment for drug-resistant seizures in tuberous sclerosis complex

Author

Thiele, Elizabeth A., Bebin, E. Martina, Bhathal, Hari, Jansen, Floor E., Kotulska, Katarzyna, Lawson, John A., O'Callaghan, Finbar J., Wong, Michael, Sahebkar, Farhad, Checketts, Daniel, Knappertz, Volker, Archer, John, Arndt, Daniel H., Barron, Todd, Cantarín-Extremera, Verónica, Sanchez-Carpintero, Rocio, Ciliberto, Michael A., Cock, Hannah, De Wit, Marie-Claire Y., Devinsky, Orrin, Falip, Merce, Filloux, Francis M., Fountain, Nathan B., Gawlowicz, Jacek, Greenwood, Robert S., Hamandi, Khalid, Joshi, Charuta, Józwiak, Sergiusz, Klein, Pavel, Kwan, Patrick, Lisewski, Pawel, Miller, Ian O., Morse, Richard P., Mostajelean, Ali S., Nolan, Danielle A., O'Brien, Terence J., Paredes, Fernando, Perry, M. Scott, Ramos, Federico J., Reutens, David, Roberts, Colin M., Saneto, Russell P., Sharp, Gregory B., Saxena, Anurag, Sparagana, Steven P., Tatachar, Priyamvada, Wheless, James W., Wirrell, Elaine C., Wong, Matthew H., Wu, Joyce Y., and Zolnowska, Marta

Abstract

Importance Efficacy of cannabidiol has been demonstrated in seizures associated with Lennox-Gastaut and Dravet syndromes but appears not yet to have been established in conditions with primarily focal seizures, such as tuberous sclerosis complex (TSC).Objective To evaluate efficacy and safety of 25-mg/kg/day and 50-mg/kg/day cannabidiol dosages vs placebo against seizures associated with TSC.Design, Setting, and Participants This double-blind, placebo-controlled randomized clinical trial (GWPCARE6) enrolled patients between April 6, 2016, and October 4, 2018; follow-up was completed on February 15, 2019. The trial was conducted at 46 sites in Australia, Poland, Spain, the Netherlands, United Kingdom, and United States. Eligible patients (aged 1-65 years) were those with a clinical diagnosis of TSC and medication-resistant epilepsy who had had at least 8 TSC-associated seizures during the 4-week baseline period, with at least 1 seizure occurring in at least 3 of the 4 weeks, and were currently taking at least 1 antiepileptic medication.Interventions Patients received oral cannabidiol at 25 mg/kg/day (CBD25) or 50 mg/kg/day (CBD50) or a matched placebo for 16 weeks.Main Outcomes and Measures The prespecified primary outcome was the change from baseline in number of TSC-associated seizures for cannabidiol vs placebo during the treatment period.Results Of 255 patients screened for eligibility, 31 were excluded and 224 were randomized. Of the 224 included patients (median [range] age, 11.4 [1.1-56.8] years; 93 female patients [41.5%]), 75 were randomized to CBD25, 73 to CBD50, and 76 to placebo, with 201 completing treatment. The percentage reduction from baseline in the type of seizures considered the primary end point was 48.6% (95% CI, 40.4%-55.8%) for the CBD25 group, 47.5% (95% CI, 39.0%-54.8%) for the CBD50 group, and 26.5% (95% CI, 14.9%-36.5%) for the placebo group; the percentage reduction from placebo was 30.1% (95% CI, 13.9%-43.3%; P

Published
2021

5. A comparison of rectal diazepam gel and placebo for acute repetitive seizures

Author

Dreifuss, Fritz E., Rosman, N. Paul, Cloyd, James C., Pellock, John M., Kuzniecky, Ruben I., Lo, Warren D., Matsuo, Fumisuke, Sharp, Gregory B., Conry, Joan A., Bergen, Donna C., and Bell, Walter E.

Subjects
Epilepsy -- Drug therapy, Diazepam -- Dosage and administration, Rectum, Medication by -- Evaluation
Abstract

A rectal suppository containing diazepam appears to be effective in people with recurring seizures. In a study of 125 children and adults with recurring seizures, the drug was more effective than a placebo in preventing recurrent seizures. Thirty-five patients experienced a side effect of the drug, most commonly, excessive sleepiness. These suppositories could be used by parents and other caregivers whenever necessary.

Published
1998

20. Idiopathic alternating anisocoria

Author

Brodsky, Michael C., Sharp, Gregory B., Fritz, Katherine J., and Corbett, James J.

Subjects
Pupil (Eye) -- Dilatation, Nervous system, Sympathetic -- Physiological aspects, Health
Published
1992

25. Patterns of Memory Performance in Children with Controlled Epilepsy onthe CVLT-C.

Author

Williams, Jane, Phillips, Tonya, Griebel, May L., Sharp, Gregory B., Lange, Bernadette, Edgar, Terence, and Simpson, Pippa

Subjects
CHILDHOOD epilepsy, MEMORY in children, LEARNING disabilities, THERAPEUTICS
Abstract

Decreased memory skills have been reported in children with epilepsy. However,standardized instruments to evaluate learning and memory in children havebeen unavailable until recently. The present study was designed to assessmemory patterns in children with epilepsy based on the California Verbal LearningTest-Children's Version (CVLT-C). The test was administered to 44 childrenwith complex partial seizures and 21 children with generalized seizures between8 and 13 years of age. Children in the study had been treated for epilepsyfor at least 6 months, had well-controlled seizures on monotherapy, and hadno evidence of anticonvulsant toxicity. Children with head injuries, learningdisabilities, or hyperactivity were excluded. Test results did not reflectdifferences in memory performance based on seizure type. Scores for the entiresample indicated intact new learning, decreased intrusions and perseverativeresponses, and better short-term than long-term delayed recall. Recognitionskills were stronger than long-term delayed recall skills and suggested thatmemory performance may be improved for these children when a multiple-choiceformat is available in academic settings. [ABSTRACT FROM AUTHOR]

Published
2001
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27. The Neurotoxicity of Cyclotrimethylenetrinitramine (RDX) in a Child: A Clinical and Pharmacokinetic Evaluation.

Author

Woody, Robert C., Kearns, Gregory L., Brewster, Marge A., Turley, Charles P., Sharp, Gregory B., and Lake, Robert S.

Abstract

Cyclotrimethylenetrinitramine (RDX) is a highly explosive compound frequently used for both military and civilian purposes. Previously reported cases of human RDX intoxication were limited to wartime settings and have described no human pharmacokinetic data. We report the first human intoxication to occur in a non-wartime setting. This intoxication presented with status epilepticus in a child and permitted the description of RDX human pharmacokinetics. It also suggested a strong association between central nervous system dysfunction and RDX intoxication. [ABSTRACT FROM AUTHOR]

Published
1986
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