Cannabinoid Use in Progressive Inflammatory brain Disease - CUPID

• Conditions: Progressive multiple sclerosis

• Registration Number: EUCTR2005-002728-33-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-29
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 492

Inclusion Criteria

-Primary or secondary progressive MS, assessed according to McDonald criteria.
-Aged 18 - 65 years.
-Disease progression (increase in physical disability, not due to major relapses) in preceding year in the opinion of the treating physician.
-EDSS of 4.0 to 6.5 inclusive.
-Willing and able to comply with study visits according to protocol for the full study period.
-Willing to abstain from cannabis use (excluding study medication) for three years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criterion:

-Any immunosuppressive or immunomodulatory therapy received in the previous 12 months.
-Any experimental therapies with potential disease modifying actions (including stem cells, goat serum and low dose naltrexone) in the previous 12 months.
-Corticosteroids received in the previous three months.
-Significant* MS relapse, likely to have had an effect on EDSS, occurring in the previous six months.
-Predominantly relapsing-remitting disease over the previous 12 months.
-Other serious illness or medical condition likely to interfere with study assessment, including ischaemic heart disease or evidence of chronic infection from any source, including pressure sores.
-Previous history of psychotic illness.
-Sesame seed allergy.
-Severe cognitive impairment such that patient is unable to provide informed consent.
-Women who are pregnant, breast-feeding or planning a pregnancy within the next three years.
-Cannabinoids (including Nabilone) taken in previous four weeks (negative urinalysis required).
-Participation in another interventional study within the last three months.
-Any other factor that might interfere with long-term study compliance in the opinion of the local research team.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified