A Study of the Long-term Safety of Sativex Use

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

December 31, 2004

Study Completion Date

December 31, 2004

Conditions
Multiple SclerosisSpasticityPain
Interventions
DRUG

GW-1000-02

Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.

Trial Locations (1)

G12 0YN

Gartnavel General Hospital, Glasgow

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY