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MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study (MUSEC)

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ClinicalTrials.gov Identifier: NCT00552604
Recruitment Status : Terminated (due to recruitment problems / based on recommendation of Independent Review Board)
First Posted : November 2, 2007
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Weleda AG
Information provided by (Responsible Party):
Institut fur Klinische Forschung, Germany

Tracking Information
First Submitted Date  ICMJE November 1, 2007
First Posted Date  ICMJE November 2, 2007
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE June 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
Change in muscle stiffness: 11-point numerical Likert scale [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00552604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
Change in pain: 11-point numerical Likert scale [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
Official Title  ICMJE 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.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Muscle Spasticity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: standardized cannabis extract
  • Placebo Comparator: 2
    matching placebo capsules, twice daily
    Intervention: Drug: Placebo
Publications * Zajicek JP, Hobart JC, Slade A, Barnes D, Mattison PG; MUSEC Research Group. Multiple sclerosis and extract of cannabis: results of the MUSEC trial. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32. doi: 10.1136/jnnp-2012-302468. Epub 2012 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 24, 2015)
279
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2007)
400
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00552604
Other Study ID Numbers  ICMJE 25-01
EUDRA-CT No.
2005-005263-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut fur Klinische Forschung, Germany
Study Sponsor  ICMJE Institut fur Klinische Forschung, Germany
Collaborators  ICMJE Weleda AG
Investigators  ICMJE
Principal Investigator: John J Zajicek, Prof. Peninsula Medical School, University of Plymouth, UK
PRS Account Institut fur Klinische Forschung, Germany
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP