drugset / Trial / NCT01743651
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arbaclofen | Small molecule | 20 mg | Oral |
| Subject | Baclofen | Small molecule | 20 mg | Oral |