CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 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/NCT00702468
NCT00702468Phase 3Completed
CompareCT.gov

A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®.

Jazz Pharmaceuticals·interventional·Posted Jun 20, 2008·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex and Placebo for Spasticity and Multiple Sclerosis. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2008
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.0 years ago

Interventions

Sativexdrug

containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief

Placebodrug

Contains no active drug and is delivered in 100 microlitre actuations by a pump action oromucosal spray