20
Participants
Start Date
January 20, 2016
Primary Completion Date
July 21, 2016
Study Completion Date
July 21, 2016
GWP42003-P 20 mg/kg/Day Dose
GWP42003-P was an oral solution containing 25 mg/mL cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
Placebo
Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
Clobazam
Participants were already on a stable dose of CLB at Baseline and continued to take a stable dose of CLB for the duration of the blinded phase of the study. CLB was administered either once or twice daily in line with the physician's preferred dosing regimen for the CLB for each participant.
Barcelona
Barcelona
Birmingham
Brighton
Leeds
Salford
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY