Trials / Terminated
TerminatedNCT03985878
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients With Duchenne Muscular Dystrophy Who Have Completed Study 4658-102
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Sarepta Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eteplirsen | Eteplirsen IV infusion once weekly. |
Timeline
- Start date
- 2019-06-26
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
- First posted
- 2019-06-14
- Last updated
- 2023-08-18
- Results posted
- 2023-08-18
Locations
4 sites across 4 countries: Belgium, France, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03985878. Inclusion in this directory is not an endorsement.