A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

October 31, 2005

Study Completion Date

October 31, 2005

Conditions
Detrusor OveractivityMultiple Sclerosis
Interventions
DRUG

Sativex®

"Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L.~Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours"

DRUG

Placebo

containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.

Trial Locations (1)

NG7 2UH

Division of Clinical Neurology, Queen's Medical Centre, Nottingham

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY