NCT02422940

Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Detailed description

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.

Conditions

• Post-ischemic Stroke

Interventions

Type	Name	Description
DRUG	dalfampridine-ER 7.5 mg
DRUG	dalfampridine-ER 10 mg

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-04-22
• Last updated: 2019-01-22
• Results posted: 2018-08-08

Locations

66 sites across 2 countries: United States, Canada