An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy

NCT03532542 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2024-09-19

Study results available
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Summary

The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).

Conditions

Interventions

DRUG

Casimersen

Casimersen solution for IV infusion

DRUG

Golodirsen

Golodirsen solution for IV infusion

Sponsors & Collaborators

  • Sarepta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sarepta Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
23 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2023-07-26
Completion
2023-07-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03532542 on ClinicalTrials.gov