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

Primary Purpose

Muscle Spasticity

Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
standardized cannabis extract
Placebo
Sponsored by
Institut fur Klinische Forschung, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity focused on measuring multiple sclerosis, muscle stiffness, spasticity, pain, treatment, cannabinoids

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peninsula Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

matching placebo capsules, twice daily

Outcomes

Primary Outcome Measures

Change in muscle stiffness: 11-point numerical Likert scale

Secondary Outcome Measures

Change in pain: 11-point numerical Likert scale

Full Information

First Posted
November 1, 2007
Last Updated
March 24, 2015
Sponsor
Institut fur Klinische Forschung, Germany
Collaborators
Weleda AG
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1. Study Identification

Unique Protocol Identification Number
NCT00552604
Brief Title
MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
due to recruitment problems / based on recommendation of Independent Review Board
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fur Klinische Forschung, Germany
Collaborators
Weleda AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity
Keywords
multiple sclerosis, muscle stiffness, spasticity, pain, treatment, cannabinoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
matching placebo capsules, twice daily
Intervention Type
Drug
Intervention Name(s)
standardized cannabis extract
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules, twice daily
Primary Outcome Measure Information:
Title
Change in muscle stiffness: 11-point numerical Likert scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in pain: 11-point numerical Likert scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Zajicek, Prof.
Organizational Affiliation
Peninsula Medical School, University of Plymouth, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peninsula Medical School
City
Plymouth
ZIP/Postal Code
PL6 8BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22791906
Citation
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.
Results Reference
derived

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MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

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