Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC study

Phase 1

• Conditions: Multiple Sclerosis

• Registration Number: EUCTR2005-005263-29-GB
• Lead Sponsor: Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

-Signed informed consent.
-Diagnosis of MS according to McDonald criteria.
-Current muscle stiffness =4 on a 11-point categorical rating scale.
-On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial.
-Stable disease for the previous 6 months in the opinion of the treating physician.
-Antispasticity medication and physiotherapy stabilised for the last 30 days.
-Patients may be ambulatory or not.
-Age 18-64.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days
-Past or present history of psychotic illness.
-Open / infected pressure sores or other source of chronic infection.
-Significant fixed tendon contractures.
-Severe cognitive impairment such that the patient is unable to provide informed consent.
-History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
-Malignancy within the past 2 years.
-Cannabinoids taken currently or in previous 30 days.
-Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
-Known hypersensitivity to cannabinoids.
-Current drug abuse, including alcohol abuse.
-Laboratory parameters outside the following limits:
Creatinine> 3x upper limit of normal
Bilirubine> 3x upper limit of normal
Transaminases> 5 x upper limit of normal
-Anticipated immunisations within the 12 weeks of trial participation.
-Other problems likely to make participation difficult at the discretion of the neurologist.
-Women who are pregnant, lactating or not using adequate contraception.
-Participation in other treatment studies currently or within the previous month.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified