CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
eteplirsendrug
Likely dose
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/NCT02420379
NCT02420379Phase 2Completed
CompareCT.gov

An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc.·interventional·Posted Apr 17, 2015·Updated Jan 25, 2021

In Brief

A Phase 2 clinical trial evaluating eteplirsen for Duchenne Muscular Dystrophy (DMD). Completed, enrolled 33 participants across 13 sites.

Detailed Summary

This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartJun 30, 2015
Primary CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.2 years ago

Interventions

eteplirsendrug

Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks.