MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
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.
What it found
The trial ended early for another reason (see below).
Reason given: due to recruitment problems / based on recommendation of Independent Review Board
What was tested
Treatment tested
- standardized cannabis extract
- Cannador
- Cannabis sativa extract
Placebo
- Placebo
What it measured
Main measures
Change in muscle stiffness: 11-point numerical Likert scale
12 weeks
The primary efficacy variable is the change in muscle stiffness after a 12-weeks treatment compared to baseline.
Change in muscle stiffness: 11-point numerical Likert scale, measured at 12 weeks.
Other measures (2)
Change in pain: 11-point numerical Likert scale
12 weeks
Pain1. Change in pain: 11-point numerical Likert scale, measured at 12 weeks 2. Amount of muscle stiffness: 11-point numerical Likert scale, measured at 2, 4, 8 and 12 weeks 3. Amount of pain: 11-point numerical Likert scale, measured at 2, 4, 8 and 12 weeks 4. Change/amount of spasms: 11-point numerical Likert scales, measured at 2, 4, 8 and 12 weeks 5. Change/amount of sleep disturbance: 11-point
Walking and mobilitySpasticityPainMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 64
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Multiple sclerosis and extract of cannabis: results of the MUSEC trial.J Neurol Neurosurg Psychiatry · 2012
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No results found
History
Started
Jun 2006
Main results due
Nov 2008
Finished
Nov 2008