Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS

Summary

The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.

Timeline

Start

2006-09

Primary completion

2008-04

Completion

2008-09

Outcome

Missed primary endpoint

registry Sativex vs Placebo; p = 0.468; Estimated treatment effect -0.17 (95% CI -0.62 to 0.29); ANCOVA NCT00391079 ↗

registry Sativex vs Placebo; p = 0.2338; Odds Ratio (OR) 1.309 (95% CI 0.840 to 2.038); Regression, Logistic NCT00391079 ↗

paper The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met PMID 23180178 ↗

Publications

• Results Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	—	Other

Indications