CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 339 enrolled
Drug / intervention
Sativex +1 moredrug
Likely dose
Sativex 27 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00391079
NCT00391079Phase 3Completed
CompareCT.gov

A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple Sclerosis

GW Pharmaceuticals Ltd·interventional·Posted Oct 23, 2006·Updated Jun 24, 2013

In Brief

A Phase 3 clinical trial evaluating Sativex and Placebo for Multiple Sclerosis. Completed, enrolled 339 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2006
Enrollment StartSep 1, 2006
Primary CompletionApr 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.7 years ago

Interventions

Sativexdrug

Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg.

Placebodrug

Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.