CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
4-aminopyridine +1 moredrug
Likely dose
4-aminopyridine 10 mgfrom 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.

Search/NCT01645787
NCT01645787Phase 3Completed
CompareCT.gov

Columbia SMA Project: 4-AP as a Potential SMA Therapeutic Agent and Biological Mechanisms of Action

Columbia University·interventional·Posted Jul 20, 2012·Updated Sep 3, 2024

In Brief

A Phase 3 clinical trial evaluating 4-aminopyridine and Placebo for Spinal Muscular Atrophy. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3 compared to placebo and whether the duration of treatment affects outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.0 years ago

Interventions

4-aminopyridinedrug

10 mg/twice daily

Placebodrug

Crossover study involving one trial with sugar pill (placebo)