NCT01743651

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: RVL Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.

Detailed description

This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks with the final study visit occurring at 19 weeks from start of achieving the target dose or 22 weeks from the Study Visit 1.

Conditions

• Spasticity
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	arbaclofen	40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day
DRUG	baclofen	80 mg/day as 20 mg baclofen administered orally 4 times per day
DRUG	Placebo	arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-12-06
• Last updated: 2022-04-25

Locations

48 sites across 3 countries: United States, Russia, Ukraine