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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eteplirsen | Antisense oligonucleotide | — | Intravenous |