A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia

Phase 3 Completed 246 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

Timeline

Start: 2005-08
Primary completion: 2006-10
Completion: 2006-10

Outcome

Mixed primary results

paper The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. PMID 24420962 ↗

paper At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray PMID 24420962 ↗

registry Sativex vs Placebo; p = 0.139; estimated mean treatment difference -0.34 (95% CI -0.79 to 0.11); ANCOVA NCT00710554 ↗

paper but which failed to reach statistical significance. PMID 24420962 ↗

Publications

Results Serpell M, Ratcliffe S, Hovorka J, Schofield M, Taylor L, Lauder H, Ehler E. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014 Aug;18(7):999-1012. doi: 10.1002/j.1532-2149.2013.00445.x. Epub 2014 Jan 13.

Drugs

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