drugset / Trial / NCT03290131
A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Arbaclofen | Small molecule | 40 mg | Oral |
| Comparator | Arbaclofen | Small molecule | 80 mg | Oral |