drugset / Trial / NCT00711646
A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
Timeline
- Start
- 2002-06
- Primary completion
- 2004-03
- Completion
- 2004-03
Outcome
Met primary endpoint
registry analysis (unspecified test); Sativex vs Placebo; p = 0.048; Estimated mean treatment difference -0.517 (95% CI -1.029 to -0.004); ANCOVA NCT00711646 ↗
paper The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). PMID 17355549 ↗
Publications
- Results Collin C, Davies P, Mutiboko IK, Ratcliffe S; Sativex Spasticity in MS Study Group. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol. 2007 Mar;14(3):290-6. doi: 10.1111/j.1468-1331.2006.01639.x.
- Di Marzo V, Centonze D. Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes. CNS Neurosci Ther. 2015 Mar;21(3):215-21. doi: 10.1111/cns.12358. Epub 2014 Dec 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nabiximols | Other / unclassified | — | Other |