NCT03756974

BX-1 in Spasticity Due to Multiple Sclerosis

A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Bionorica SE · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Spasticity Due to Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BX-1	BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
DRUG	Placebo	Placebo of BX-1, oral solution

Timeline

• Start date: 2019-02-18
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2018-11-28
• Last updated: 2021-05-05

Locations

40 sites across 5 countries: Czechia, Germany, Hungary, Poland, Spain