NCT02271217

A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.

This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

Detailed description

This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Conditions

• Post-Ischemic Stroke

Interventions

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

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2014-10-22
• Last updated: 2018-06-07
• Results posted: 2017-12-04

Locations

74 sites across 2 countries: United States, Canada