drugset / Trial / NCT01844232
One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity
NaSequentialOpen-labelTreatment
Summary
Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.
Timeline
- Start
- 2013-04
- Primary completion
- 2014-12
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arbaclofen | Small molecule | 20 mg | — |
| Subject | Arbaclofen | Small molecule | 30 mg | — |
| Subject | Arbaclofen | Small molecule | 40 mg | — |