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A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Spasticity Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05179577
Study type Interventional
Source RVL Pharmaceuticals, Inc.
Contact Joann Stavole
Phone 9088091343
Email jstavole@rvlpharma.com
Status Not yet recruiting
Phase Phase 3
Start date January 2025
Completion date April 2026
View Details
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