drugset / Trial / NCT03985878

A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)

NCT03985878 ↗

Phase 2 Terminated 15 enrolled Sarepta Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have successfully completed the 96-week eteplirsen Study 4658-102.

Timeline

Start
2019-06-26
Primary completion
2022-08-31
Completion
2022-08-31

Outcome

Outcome not reported

Stopped: “Participants were either transitioned to a post-trial access program or another Sarepta study, or they declined further treatment. There are no safety concerns with Eteplirsen.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Eteplirsen Antisense oligonucleotide — Intravenous