CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
AVI-4658 (Eteplirsen)drug
Likely dose
AVI-4658 (Eteplirsen) 30 mg/kgfrom 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/NCT01540409
NCT01540409Phase 2Completed
CompareCT.gov

Open-Label, Multiple-Dose, Efficacy, Safety, and Tolerability Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy Who Participated in Study 4658-US-201

Sarepta Therapeutics, Inc.·interventional·Posted Feb 28, 2012·Updated Mar 30, 2020

In Brief

A Phase 2 clinical trial evaluating AVI-4658 (Eteplirsen) for Duchenne Muscular Dystrophy (DMD). Completed, enrolled 12 participants across 11 sites.

Detailed Summary

The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy (DMD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2012
Enrollment StartFeb 27, 2012
Primary CompletionApr 15, 2016
Study CompletionAug 16, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.3 years ago

Interventions

AVI-4658 (Eteplirsen)drug

Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.