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Clinical Trial Summary

To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spasticity medication


Clinical Trial Description

The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an oral solution containing dronabinol, over placebo in patients with spasticity due to MS not sufficiently controlled by their current anti-spasticity medication. The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not showing sufficient response to their current anti-spasticity treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03756974
Study type Interventional
Source Bionorica SE
Contact
Status Completed
Phase Phase 3
Start date February 18, 2019
Completion date March 30, 2021