CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 160 enrolled
Drug / intervention
GW-1000-02 +1 moredrug
Likely dose
GW-1000-02 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/NCT01610700
NCT01610700Phase 3Completed
CompareCT.gov

Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

Jazz Pharmaceuticals·interventional·Posted Jun 4, 2012·Updated Jan 12, 2023

In Brief

A Phase 3 clinical trial evaluating GW-1000-02 and Placebo for Multiple Sclerosis. Completed, enrolled 160 participants across 1 site.

Detailed Summary

A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 4, 2012
Enrollment StartMay 1, 2001
Primary CompletionJul 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago

Interventions

GW-1000-02drug

Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Placebodrug

Each actuation of placebo delivered the excipients only.