MedTrace Logo

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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-18

Study results available
· View outcomes & findings →

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

DRUG

Eteplirsen

Eteplirsen IV infusion once weekly.

Sponsors & Collaborators

  • Sarepta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sarepta Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985878 on ClinicalTrials.gov