18
Participants
Start Date
March 11, 2016
Primary Completion Date
June 7, 2017
Study Completion Date
June 7, 2017
GWP42003-P
GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) 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). Participants received up to a maximum of 30 mg/kg/day.
Clobazam
Participants were taking CLB upon entry into the OLE phase of the trial. CLB was not an investigational medicinal product (IMP) for the OLE phase and was not administered by the Sponsor, but was administered at the physician's discretion, as required for each participant. CLB could be stopped, if clinically indicated, without impact on analysis.
Barcelona
Barcelona
Birmingham
Brighton
Leeds
Salford
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY