drugset / Trial / NCT01844232

One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

NCT01844232

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

EvaluationDrugModalityDoseRoute
Subject Arbaclofen Small molecule 20 mg
Subject Arbaclofen Small molecule 30 mg
Subject Arbaclofen Small molecule 40 mg

Indications