NCT01359566

Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Arbaclofen placarbil 15 mg BID	arbaclofen placarbil 15 mg BID
DRUG	Placebo	Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
DRUG	Arbaclofen placarbil 30 mg BID	arbaclofen placarbil 30 mg BID
DRUG	Arbaclofen placarbil 45 mg BID	arbaclofen placarbil 45 mg BID

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-05-24
• Last updated: 2021-02-21

Locations

28 sites across 1 country: United States