An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 11, 2016

Primary Completion Date

June 7, 2017

Study Completion Date

June 7, 2017

Conditions
Epilepsy
Interventions
DRUG

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.

DRUG

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.

Trial Locations (6)

08035

Barcelona

08036

Barcelona

B15 2FG

Birmingham

BN2 5BE

Brighton

LS1 3EX

Leeds

M6 8HD

Salford

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY