NCT00711646

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Spasticity
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Sativex®	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
DRUG	Placebo	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.

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2008-07-09
• Last updated: 2023-05-06
• Results posted: 2012-09-14

Locations

1 site across 1 country: United Kingdom