A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 20, 2016

Primary Completion Date

July 21, 2016

Study Completion Date

July 21, 2016

Conditions
Epilepsy
Interventions
DRUG

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).

DRUG

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).

DRUG

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.

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