At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 430 enrolled
Drug / intervention
Dalfampridine-ER 5mg +2 moredrug
Likely dose
Dalfampridine-ER 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dalfampridine-ER 5mg, Dalfampridine-ER 10mg, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 430 participants across 70 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedApr 2011
Primary CompletionApr 2012
Study CompletionJul 2012
TodayJul 2026
First PostedApr 4, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.2 years ago
Interventions
Dalfampridine-ER 5mgdrug
5mg, twice daily
Dalfampridine-ER 10mgdrug
10mg, twice daily
Placeboother
placebo, twice daily