A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.

PHASE3CompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

June 30, 2002

Primary Completion Date

March 31, 2004

Study Completion Date

March 31, 2004

Conditions
SpasticityMultiple Sclerosis
Interventions
DRUG

Sativex®

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

DRUG

Placebo

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Trial Locations (1)

RG1 5AN

Royal Berkshire Hospital, Reading

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY