CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 189 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/NCT00711646
NCT00711646Phase 3Completed
CompareCT.gov

A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis.

Jazz Pharmaceuticals·interventional·Posted Jul 9, 2008·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex® and Placebo for Spasticity and Multiple Sclerosis. Completed, enrolled 189 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpasticity, Multiple Sclerosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2008
Enrollment StartJun 1, 2002
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

Sativex®drug

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Placebodrug

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.