CCMR One
What it found
The main measure was safety, drug levels or similar, not whether the treatment works.
“Participants who received bexarotene had a higher mean number of adverse events (6·12 [SD 3·09]; 159 events in total) than did participants who received placebo (1·63 [SD 1·50]; 39 events in total).”Read by software from the paper's abstract
6 months
| Group | n | Value |
|---|---|---|
| bexarotene | 26 | 6.12 (SD 3.09) mean adverse events; 159 events in total |
| placebo | 26 | 1.63 (SD 1.50) mean adverse events; 39 events in total |
Total participants: 52
Read by software from the paper's abstract
What was tested
Treatment tested
- Bexarotene
Retinoid X receptor agonist
What it measured
Main measures
The primary endpoint is adverse events and withdrawals atributable to taking bexarotene.
SafetyNumber of adverse events and withdrawals attributable to bexarotene are determined at 9 months.
Safety
Other measures (2)
The secondary endpoint is mean lesional Magnetisation Transfer Ratio (MTR) between month 0 and month 6 for lesions selected for each patient whose MTR lies below the within-patient median.
MRI lesionsMyelin repairChange in mean lesional MTR between month 0 and month 6 for lesions selected for each patient.
MRI lesionsMyelin repair
Who could take part
Relapsing MS · 30 to 50
Inclusion: - Informed consent Exclusion: Patients who are:
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective is to establish the safety and tolerability of bexarotene in the treatment of relapsing remitting multiple sclerosis.
Papers
Results
Paper 34418398Participants who received bexarotene had a higher mean number of adverse events (6·12 [SD 3·09]; 159 events in total) than did participants who received placebo (1·63 [SD 1·50]; 39 events in total).
Read by software from the paper's abstract
Results
Paper 36116011
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History
Started
Jan 2015
Finished
Nov 2019
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