A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis

NCT01604265 ↗

Phase 3 Completed 66 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the ability of Sativex to relieve central neuropathic pain in multiple sclerosis subjects.

Timeline

Start: 2002-03
Primary completion: 2002-08
Completion: 2002-08

Outcome

Met primary endpoint

paper CBM was superior to placebo in reducing the mean intensity of pain (CBM mean change -2.7, 95% CI: -3.4 to -2.0, placebo -1.4 PMID 16186518 ↗

registry analysis (unspecified test); Sativex vs Placebo; p = 0.005; Estimated mean treatment difference -1.25 (95% CI -2.11 to -0.39); ANCOVA NCT01604265 ↗

Publications

Results Rog DJ, Nurmikko TJ, Friede T, Young CA. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology. 2005 Sep 27;65(6):812-9. doi: 10.1212/01.wnl.0000176753.45410.8b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	2.5 mg	Other