At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 337 enrolled

Drug / intervention

Sativex +1 moredrug

Likely dose

Sativex 27mgfrom 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/NCT01599234

NCT01599234Phase 3Completed

Compare CT.gov

A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis.

Jazz Pharmaceuticals·interventional·Posted May 15, 2012·Updated May 3, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex and Placebo for Multiple Sclerosis. Completed, enrolled 337 participants across 1 site.

Detailed Summary

The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Sclerosis

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2005

Primary CompletionDec 2005

First PostedMay 2012

TodayJul 2026

First PostedMay 15, 2012

Enrollment StartMar 1, 2005

Primary CompletionDec 1, 2005

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 14.1 years ago

Interventions

Sativexdrug

Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (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

Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.