Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Participants are randomly allocated to one of two groups in a 2:1 ratio (intervention:control)
Intervention group: Participants take a maximum of 28mg/day oral tetrahydrocannabinol (THC) for six mont
Sponsors
Plymouth Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary/secondary progressive multiple sclerosis 2. Worsening disability 3. Age 18-65 4. EDSS score 4 to 6.5
Exclusion criteria
Exclusion criteria: 1. Immunodulation or immunosuppressive therapy 2. Steroids or cannabinoids recently 3. Psychotic illness 4. Cognitive impairment 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 17/07/09: 1. Physician-based EDSS: time to EDSS progression of at least one point from a baseline EDSS of 4.0, 4.5 or 5.0 or at least 0.5 points from a baseline EDSS =5.5. Once identified, deterioration must be confirmed at the next scheduled six monthly visit. 2. Change in Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) 20-point physical subscale (MSIS-29phys) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed