In this double-blind, placebo-controlled trial, we randomly assigned children and young adults with the Dravet syndrome and drug-resistant. Long-term cannabidiol treatment in patients with Dravet syndrome: An associated with Dravet syndrome (DS) in a randomized, double-blind, enroll in a long-term open-label extension trial, GWPCARE5 (NCT). We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome. METHODS: In this double-blind, placebo-controlled trial, we.
syndrome Double-blind Dravet trial in
The Caregiver Global Impression of Change, a seven-point scale, was used as a secondary end-point measure. Adverse events led with withdrawal from the trial of eight patients in the CBD group and one in the placebo group.
Other adverse events that occurred more frequently in the CBD group than the placebo group included diarrhea, vomiting, fatigue, pyrexia, and liver-function test result abnormalities. The importance of this study is that, unlike most other antiseizure medication trials, it assesses a treatment in a specific epilepsy syndrome with a known genetic basis.
CBD resulted in a significant decrease of convulsive seizures and seizures of all types in Dravet syndrome, a pharmacoresistant epilepsy known to be associated with high mortality rates. The role of cannabinoid receptors in modulating seizure activity has been studied. For example, mutant mice that lack expression of the cannabinoid receptor type 1 CB1 in principal forebrain neurons but not in adjacent inhibitory interneurons exhibited excessive seizures in the kainic acid model 4.
Unlike the wild type, mutant mice failed to mount increased levels of anandamide in the hippocampus. Another study demonstrated that cannabinoids abolished seizures in rats using the pilocarpine model, whereas CB1 antagonism resulted in seizure exacerbation and status epilepticus 5.
Why these mechanisms appear to improve seizures in Dravet syndrome, and whether the results benefit other epilepsies remain to be established. National Center for Biotechnology Information , U. Journal List Epilepsy Curr v.
Mohamad Koubeissi , MD. Author information Copyright and License information Disclaimer. Authors have a Conflict of Interest disclosure which is posted under the Supplemental Materials link. Supplementary Material Click here for additional data file. A listing of Dravet Syndrome medical research trials actively recruiting patient volunteers. Search for closest city to find more detailed information on a research study in your area.
This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.
This study is a 1: A day screening period prior to randomization to establish baseline parameters will precede the treatment period, which will consist of a two-week titration period followed by a week maintenance period. This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the efficacy, safety, and pharmacokinetics of ZX when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Interactions between cannabidiol and commonly used antiepileptic drugs.
Cutter , Yuliang Liu , Jerzy P. Exogenous cannabinoids as substrates, inhibitors, and inducers of human drug metabolizing enzymes: Stephen Marc Stout , Nina M. Jacqueline S Gofshteyn , Angus A. Cannabinoids in treatment-resistant epilepsy: A review Brooke K. O'Connell , David S.
Dravet Syndrome Clinical Trials
Dravet Syndrome Clinical Research Trial Listings in Rare Diseases and Disorders This study is a randomized, double-blind, week comparison of two. Full Title: Population pharmacokinetic study in Dravet's syndrome patients treated Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two. ZX (Fenfluramine HCl Oral Solution) in Dravet Syndrome: Results of a Phase 3,. Randomized, Double-Blind, Placebo-Controlled Trial. Lieven Lagae1.