Add-On Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex A Placebo-Controlled Randomized Clinical Trial
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
JAMA NEUROLOGY | AMER MEDICAL ASSOC | Published : 2020
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, U..View full abstract
The study was supported by GW Research Ltd.