Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
SpasticityMultiple Sclerosis
Interventions
DRUG

Sativex

containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief

DRUG

Placebo

Contains no active drug and is delivered in 100 microlitre actuations by a pump action oromucosal spray

Trial Locations (1)

NR31 6LA

James Paget University Hospital NHS Foundation Trust, Gorleston-on-Sea

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY