MedTrace Logo

MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

NCT00552604 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2015-03-25

No results posted yet for this study

Summary

Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.

Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.

Study treatment:

Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.

Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.

Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.

Study sites: 20 neurological clinics in the United Kingdom.

Conditions

  • Muscle Spasticity

Interventions

DRUG

standardized cannabis extract

Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily

DRUG

Placebo

Matching placebo capsules, twice daily

Sponsors & Collaborators

  • Weleda AG

    collaborator INDUSTRY

  • Institut fur Klinische Forschung, Germany

    lead OTHER

Principal Investigators

  • John J Zajicek, Prof. · Peninsula Medical School, University of Plymouth, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00552604 on ClinicalTrials.gov