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

Phase 3 Completed 135 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

Timeline

Start: 2002-08
Primary completion: 2005-10
Completion: 2005-10

Outcome

Missed primary endpoint

registry analysis (unspecified test); Sativex vs Placebo; p = 0.569; Estimated mean treatment difference -0.11 (95% CI -0.47 to 0.26); ANCOVA NCT00678795 ↗

paper Although the primary endpoint did not reach statistical significance PMID 20829244 ↗

Publications

Results Kavia RB, De Ridder D, Constantinescu CS, Stott CG, Fowler CJ. Randomized controlled trial of Sativex to treat detrusor overactivity in multiple sclerosis. Mult Scler. 2010 Nov;16(11):1349-59. doi: 10.1177/1352458510378020. Epub 2010 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	25 mg/ml	Other
Subject	Nabiximols	Other / unclassified	27 mg/ml	Other