Condition category
Nervous System Diseases
Date applied
10/10/2007
Date assigned
17/10/2007
Last edited
03/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.msmusecstudy.com

Contact information

Type

Scientific

Primary contact

Prof John Zajicek

ORCID ID

Contact details

Peninsula Medical School
ITTC Building 1
Tamar Science Park
1 Davy Road
Plymouth
PL6 8BX
United Kingdom
+44 (0)1752 315 250
John.ZAJICEK@phnt.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00552604

Protocol/serial number

'25-01

Study information

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)

Acronym

MUSEC

Study hypothesis

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

Multi-centre Research Ethics Committee For Scotland, 31/01/2006, ref: 05/MRE10/97

Study design

Multi-centre randomised double-blind placebo-controlled two-arm parallel study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Cannabis sativa extract

Primary outcome measures

Change in muscle stiffness: 11-point numerical Likert scale, measured at 12 weeks.

Secondary outcome measures

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

Overall trial start date

20/06/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

20/06/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Peninsula Medical School
Plymouth
PL6 8BX
United Kingdom

Sponsor information

Organisation

Institute for Clinical Research (Institut fur klinische Forschung) (Germany)

Sponsor details

Hardenbergstr. 19
Berlin
D-10623
Germany
+49 (0)30 315 744 71
martin.schnelle@ikf-berlin.de

Sponsor type

Research organisation

Website

http://www.ikf-berlin.de

Funders

Funder type

Industry

Funder name

Weleda AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22791906

Publication citations

Additional files

Editorial Notes