BX-1 in spasticity due to MS
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Dronabinol
Cannabinoid CB1 receptor agonist
What it measured
Main measures
Responder analysis: proportion of patients showing improvement in spasticity (change from baseline corresponding to the mean NRS-S score during 7 days prior to randomisation) of 18% or more in average NRS-S assessment at end of treatment (mean NRS-S score during 7 days prior to Visit 6).
Spasticity
Other measures (1)
Secondary efficacy endpoints:
Who could take part
MS (type not specified)
Inclusion: 1. Male or female patients aged 18 to 65 years Exclusion: 1. Any present disease other than MS that could affect spasticity (e.g. traumatic brain injury, spinal cord injury, brain damage due to a lack of oxygen, stroke, encephalitis, meningitis)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the trial is to demonstrate superiority of BX-1 over placebo by comparison of proportions of NRS-S responders between the two treatment groups.
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History
Started
Aug 2018
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