Conditions: Multiple Sclerosis Spasticity
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 137
Healthy volunteers: no

Brief summary:
An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.

Detailed description:
Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.

Arms:
arm 1: Active treatment

Interventions: intervention 1: GW-1000-02
Intervention descriptions: intervention 1: Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Protocol document: