CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Amifampridine Phosphate +1 moredrug
Likely dose
Amifampridine Phosphate 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/NCT03781479
NCT03781479Phase 2Completed
CompareCT.gov

A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3

Catalyst Pharmaceuticals, Inc.·interventional·Posted Dec 20, 2018·Updated Jun 1, 2021

In Brief

A Phase 2 clinical trial evaluating Amifampridine Phosphate and Placebo Oral Tablet for Muscular Atrophy, Spinal. Completed, enrolled 13 participants across 1 site.

Detailed Summary

A two-period, two-treatment, crossover study to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with spinal muscular atrophy (SMA) Type 3.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Atrophy, Spinal
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 20, 2018
Enrollment StartJan 21, 2019
Primary CompletionJul 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.5 years ago

Interventions

Amifampridine Phosphatedrug

Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.

Placebo Oral Tabletdrug

Placebo Oral Tablet