NCT01328379

Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.

Detailed description

The current study is designed as a prospective placebo-controlled trial to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in MS patients during a four-week period of treatment.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Dalfampridine-ER 5mg	5mg, twice daily
DRUG	Dalfampridine-ER 10mg	10mg, twice daily
OTHER	Placebo	placebo, twice daily

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-07-01
• First posted: 2011-04-04
• Last updated: 2013-09-05
• Results posted: 2013-08-13

Locations

70 sites across 1 country: United States