CUPID
What it found
The main measure did not show a significant benefit.
“145 patients in the dronabinol group had EDSS score progression (0·24 first progression events per patient-year; crude rate) compared with 73 in the placebo group (0·23 first progression events per patient-year; crude rate); HR for prespecified primary analysis was 0·92 (95% CI 0·68-1·23; p=0·57).”Read by software from the paper's abstract
36 months
| Group | n | Value |
|---|---|---|
| Dronabinol | 329 | 145 patients with EDSS progression (0.24 first progression events per patient-year); mean yearly change in MSIS-29-PHYS 0.62 points (SD 3.29) |
| Placebo | 164 | 73 patients with EDSS progression (0.23 first progression events per patient-year); mean yearly change in MSIS-29-PHYS 1.03 points (3.74) |
hazard ratio 0.92
p = 0.57
Total participants: 498
Read by software from the paper's abstract
What was tested
Treatment tested
- Dronabinol
Cannabinoid CB1 receptor agonist
What it measured
Main measures
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.
Disability progressionAdded 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
Disability progressionQuality of life (reported by participants)
Other measures (1)
Not provided at time of registration
Who could take part
Progressive MS · 18 to 65
Inclusion: Inclusion criteria: Exclusion: Exclusion criterion:
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The study aims to address the following questions:
Papers
Results
The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis.Health Technol Assess · 2015
Results
results145 patients in the dronabinol group had EDSS score progression (0·24 first progression events per patient-year; crude rate) compared with 73 in the placebo group (0·23 first progression events per patient-year; crude rate); HR for prespecified primary analysis was 0·92 (95% CI 0·68-1·23; p=0·57).
Read by software from the paper's abstract
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History
Started
Dec 2005
Finished
Jun 2011
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