MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

NCT00552604 | Terminated Phase 3 DMC

• 3 other identifiers: 25-01EUDRA-CT No.2005-005263-29
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity

Keywords

multiple sclerosis; muscle stiffness; spasticity; pain; treatment; cannabinoids

Outcome Measures

Primary Outcomes (1)

• Change in muscle stiffness: 11-point numerical Likert scale

  12 weeks

Secondary Outcomes (1)

• Change in pain: 11-point numerical Likert scale

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

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: standardized cannabis extract

2

PLACEBO COMPARATOR

matching placebo capsules, twice daily

Drug: Placebo

Interventions

standardized cannabis extract DRUG

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

1

Placebo DRUG

Matching placebo capsules, twice daily

2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut fur Klinische Forschung, Germany: lead
• Weleda AG: collaborator

Study Sites (1)

Peninsula Medical School

Plymouth, Plymouth, PL6 8BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22791906 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John J Zajicek, Prof.

  Peninsula Medical School, University of Plymouth, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: June 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

GB (1)