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

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

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Cannabis GW-1000

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

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
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 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
2: Placebo Comparator 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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Institut fuer Klinische Forschung, Germany ( Dr Marcus Reif, Head of R&D )
Study ID Numbers:	25-01, EUDRA-CT No., 2005-005263-29
First Received:	November 1, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00552604
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

Study placed in the following topic categories:

Autoimmune Diseases

Demyelinating Diseases

Demyelinating diseases

Pain

Sclerosis

Signs and Symptoms

Muscle Spasticity

Multiple Sclerosis

Muscular Diseases

Musculoskeletal Diseases

Muscle Hypertonia

Demyelinating Autoimmune Diseases, CNS

Neurologic Manifestations

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Neuromuscular Manifestations

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Institut fur Klinische Forschung, Germany Weleda AG
Information provided by:	Institut fur Klinische Forschung, Germany
ClinicalTrials.gov Identifier:	NCT00552604