drugset / Trial / NCT01743651

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

NCT01743651

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-11
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Arbaclofen Small molecule 20 mg Oral
Subject Baclofen Small molecule 20 mg Oral

Indications