Authors
Elizabeth A Thiele, E Martina Bebin, Hari Bhathal, Floor E Jansen, Katarzyna Kotulska, John A Lawson, Finbar J O'Callaghan, Michael Wong, Farhad Sahebkar, Daniel Checketts, Volker Knappertz, John Archer, Daniel H Arndt, Todd Barron, Verónica Cantarín-Extremera, Rocio Sanchez-Carpintero, Michael A Ciliberto, Hannah Cock, Marie-Claire Y De Wit, Orrin Devinsky, Merce Falip, Francis M Filloux, Nathan B Fountain, Jacek Gawlowicz, Robert S Greenwood, Khalid Hamandi, Charuta Joshi, Sergiusz Jóźwiak, Pavel Klein, Patrick Kwan, Pawel Lisewski, Ian O Miller, Richard P Morse, Ali S Mostajelean, Danielle A Nolan, Terence J O'Brien, Fernando Paredes, M Scott Perry, Federico J Ramos, David Reutens, Colin M Roberts, Russell P Saneto, Gregory B Sharp, Anurag Saxena, Steven P Sparagana, Priyamvada Tatachar, James W Wheless, Elaine C Wirrell, Matthew H Wong, Joyce Y Wu, Marta Żołnowska, GWPCARE6 Study Group
Publication date
2021/3/1
Journal
JAMA neurology
Volume
78
Issue
3
Pages
285-292
Publisher
American Medical Association
Description
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 …
Total citations
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