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A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.

Multiple Sclerosis Clinical Trial

Official title:
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.

Clinical Trial Summary

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

Clinical Trial Description

This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00711646
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date June 2002
Completion date March 2004
View Details
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