CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 572 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/NCT00681538
NCT00681538Phase 3Completed
CompareCT.gov

A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study.

Jazz Pharmaceuticals·interventional·Posted May 21, 2008·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex® and Placebo for Spasticity and Multiple Sclerosis. Completed, enrolled 572 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2008
Enrollment StartJan 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.1 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 dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg)

Placebodrug

containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).