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Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients

NCT01645787 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-09-03

Study results available
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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.

Conditions

Interventions

DRUG

4-aminopyridine

10 mg/twice daily

DRUG

Placebo

Crossover study involving one trial with sugar pill (placebo)

Sponsors & Collaborators

Principal Investigators

  • Claudia A. Chiriboga, MD, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2015-09-30
Completion
2015-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645787 on ClinicalTrials.gov