drugset / Trial / NCT00702468
Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-01
- Completion
- 2009-01
Outcome
Met primary endpoint
registry analysis (unspecified test); Sativex vs Placebo; p = 0.013; Odds Ratio (OR) 0.335 (90% CI 0.162 to 0.691); Chi-squared NCT00702468 ↗
paper Primary outcome of time to treatment failure was significantly in favour of Sativex (p = 0.013). PMID 21878454 ↗
Publications
- Results Notcutt W, Langford R, Davies P, Ratcliffe S, Potts R. A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex(R) (nabiximols). Mult Scler. 2012 Feb;18(2):219-28. doi: 10.1177/1352458511419700. Epub 2011 Aug 30.
- 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 | 0.1 ml | Other |