NCT03319732

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: RVL Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, open-label, long-term extension study to evaluate the safety and tolerability of oral AERT in patients with spasticity due to MS. Subjects from the double blind study (Study OS440-3004) may rollover into this open-label extension study, as well as de novo subjects. The maintenance dose will be 80 mg/day or the highest tolerated dose. Once the subject has reached the maintenance dose, they will remain on that dose for approximately 1 year.

Conditions

• Multiple Sclerosis
• Spasticity, Muscle

Interventions

Type	Name	Description
DRUG	Arbaclofen	Arbaclofen is the active R enantiomer of baclofen.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-01-27
• Completion: 2020-06-11
• First posted: 2017-10-24
• Last updated: 2022-08-09
• Results posted: 2022-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study