drugset / Trial / NCT01599234
A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis
Timeline
- Start
- 2005-03
- Primary completion
- 2005-12
- Completion
- 2005-12
Outcome
Missed primary endpoint
registry Sativex vs Placebo; p = 0.220; Estimated mean treatment difference -0.23 (95% CI -0.59 to 0.14); ANCOVA NCT01599234 ↗
Publications
- Results Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P, Powell K, Notcutt W, O'Leary C, Ratcliffe S, Novakova I, Zapletalova O, Pikova J, Ambler Z. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res. 2010 Jun;32(5):451-9. doi: 10.1179/016164109X12590518685660. Epub 2010 Mar 19.
- 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 | 60 mg | Other |
| Subject | Nabiximols | Other / unclassified | 65 mg | Other |