MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

Muscle Spasticity Clinical Trial

— MUSEC  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00552604
• Other study ID #: 25-01
• Secondary ID: EUDRA-CT No.2005
• Status: Terminated
• Phase: Phase 3
• First received: November 1, 2007
• Last updated: March 24, 2015
• Start date: June 2006
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: Institut fur Klinische Forschung, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 279
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

• Stable disease for the previous 6 months.

• Antispasticity medication and physiotherapy stabilised for the last 30 days.

• Patients may be ambulatory or not.

• Age 18-64.

Exclusion Criteria:

• Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity

Intervention

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
• Placebo
Matching placebo capsules, twice daily

Locations

Country	Name	City	State
United Kingdom	Peninsula Medical School	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
Institut fur Klinische Forschung, Germany	Weleda AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle stiffness: 11-point numerical Likert scale		12 weeks	No
Secondary	Change in pain: 11-point numerical Likert scale		12 weeks	No