MedTrace Logo

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

NCT00711646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2023-05-06

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Christine Collin, MB BS MRCP FRCP · Royal Berkshire Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711646 on ClinicalTrials.gov