MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study - Full Text View

Sponsor:	Institut fur Klinische Forschung, Germany
Collaborator:	Weleda AG
Information provided by:	Institut fur Klinische Forschung, Germany
ClinicalTrials.gov Identifier:	NCT00552604

Purpose

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.

Condition	Intervention	Phase
Muscle Spasticity	Drug: standardized cannabis extract Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by Institut fur Klinische Forschung, Germany:

Primary Outcome Measures:

Change in muscle stiffness: 11-point numerical Likert scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in pain: 11-point numerical Likert scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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 Comparator: 2 matching placebo capsules, twice daily	Drug: Placebo Matching placebo capsules, twice daily

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552604

Locations

United Kingdom
Peninsula Medical School
Plymouth, United Kingdom, PL6 8BX

Sponsors and Collaborators

Institut fur Klinische Forschung, Germany

Weleda AG

Investigators

Principal Investigator:

John J Zajicek, Prof.

Peninsula Medical School, University of Plymouth, UK

More Information

No publications provided

Responsible Party:	Dr Marcus Reif, Head of R&D, Institut fuer Klinische Forschung, Germany
ClinicalTrials.gov Identifier:	NCT00552604 History of Changes
Other Study ID Numbers:	25-01, EUDRA-CT No., 2005-005263-29
Study First Received:	November 1, 2007
Last Updated:	January 26, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institut fur Klinische Forschung, Germany:

multiple sclerosis
muscle stiffness
spasticity

pain
treatment
cannabinoids

Additional relevant MeSH terms:

Multiple Sclerosis
Muscle Spasticity
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012