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Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01743651
Study type Interventional
Source RVL Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date November 2012
Completion date April 2014
View Details
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