drugset / Trial / NCT03290131

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

NCT03290131

RandomizedParallel-groupSingle-blindTreatment

Summary

Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.

Timeline

Start
2018-01-28
Primary completion
2018-12-03
Completion
2019-01-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Arbaclofen Small molecule 40 mg Oral
Comparator Arbaclofen Small molecule 80 mg Oral

Indications