MUltiple Sclerosis and Extract of Cannabis (MUSEC): a 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 (MS)

ISRCTN	ISRCTN42223114
DOI	https://doi.org/10.1186/ISRCTN42223114
ClinicalTrials.gov (NCT)	NCT00552604
Protocol serial number	'25-01
Sponsor	Institute for Clinical Research (Institut fur klinische Forschung) (Germany)
Funder	Weleda AG (Germany)

Submission date: 10/10/2007
Registration date: 17/10/2007
Last edited: 03/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Zajicek
Scientific

Peninsula Medical School
ITTC Building 1
Tamar Science Park
1 Davy Road
Plymouth
PL6 8BX
United Kingdom

Phone	+44 (0)1752 315 250
Email	John.ZAJICEK@phnt.swest.nhs.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised double-blind placebo-controlled two-arm parallel study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	MUltiple Sclerosis and Extract of Cannabis (MUSEC): a 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 (MS)
Study acronym	MUSEC
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.
Ethics approval(s)	Multi-centre Research Ethics Committee For Scotland, 31/01/2006, ref: 05/MRE10/97
Health condition(s) or problem(s) studied	Multiple sclerosis
Intervention	1. Cannabis extract (delta-9-tetrahydrocannabinol [THC] 2.5 mg, Cannabidiol [CBD] 1.25 mg per capsule) - start dose 5 mg THC per day, followed by individual dose titration with increase of 5 mg THC every 3 days, maximal dose 25 mg, administered orally as 2 equal doses per day based on tolerability 2. Matched placebo There is no follow up for the trial (total duration of trial is 12 weeks from randomisation). Added 12/09/2008: Recruitment for the MUSEC Study has now been completed. Last patient randomised was 04/09/2008. The Last Patient Last Visit is expected in November 2008.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Cannabis sativa extract
Primary outcome measure(s)	Change in muscle stiffness: 11-point numerical Likert scale, measured at 12 weeks.
Key secondary outcome measure(s)	1. 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 numerical Likert scales, measured at 2, 4, 8 and 12 weeks 6. Disease-specific Quality of Life: Multiple Sclerosis Spasticity Scale (MSSS)-88 and Multiple Sclerosis Impact Scale (MSIS)-29, measured at 4 and 12 weeks 7. Patient-rated walking ability: Multiple Sclerosis Walking Scale (MSWS)-12, measured at 4 and 12 weeks
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Diagnosis of MS according to McDonald criteria 2. Current muscle stiffness greater than or equal to 4 on a 11-point categorical rating scale 3. On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial 4. Stable disease for the previous 6 months in the opinion of the treating physician 5. Antispasticity medication and physiotherapy stabilised for the last 30 days 6. Patients may be ambulatory or not 7. Age 18 - 64 years
Key exclusion criteria	1. Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days 2. Open/infected pressure sores or other source of chronic infection 3. Significant fixed tendon contractures 4. Cannabinoids taken currently or in previous 30 days 5. Positive qualitative urinary test on cannabinoids at screening visit 6. Laboratory parameters outside the following limits: 6.1. Creatinine greater than 3 x upper limit of normal 6.2. Bilirubin greater than 3 x upper limit of normal 6.3. Transaminases greater than 5 x upper limit of normal
Date of first enrolment	20/06/2006
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Peninsula Medical School

Plymouth
PL6 8BX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes