Clinical Trials Logo
  1. Home
  2. Muscular Dystrophy, Duchenne
  3. NCT03769116

A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)

Muscular Dystrophy, Duchenne Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial for Duchenne Muscular Dystrophy Using SRP-9001

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in DMD participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded, placebo-controlled periods (Part 1 and Part 2), and an open-label follow-up period (Part 3). Participants who are randomized to placebo in Part 1 will have the opportunity for treatment with delandistrogene moxeparvovec in Part 2. In order to provide a uniform approach to monitoring long-term safety and efficacy in participants who received SRP-9001 in a clinical trial, the Sponsor has amended Study Completion for this study to occur at Week 130. Therefore, participants have transitioned and will complete the remainder of the Part 3 follow up visits in a long-term extension study, SRP-9001-305 (NCT05967351).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03769116
Study type Interventional
Source Sarepta Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 5, 2018
Completion date August 16, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01865084 - A Study of Tadalafil for Duchenne Muscular Dystrophy Phase 3
Completed NCT00243789 - Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy Phase 1/Phase 2
Completed NCT00033189 - An Open-label Pilot Study of Coenzyme Q10 in Steroid-Treated Duchenne Muscular Dystrophy Phase 2
Completed NCT03703882 - Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy Phase 3
Enrolling by invitation NCT04626674 - A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD) Phase 1
Completed NCT02286947 - Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy Phase 2
Completed NCT03406780 - A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2
Completed NCT01826487 - Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Phase 3
Completed NCT02710591 - Rimeporide in Patients With Duchenne Muscular Dystrophy Phase 1
Completed NCT01826422 - Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients N/A
Completed NCT00102453 - Pentoxifylline in Duchenne Muscular Dystrophy Phase 1/Phase 2
Terminated NCT02090959 - An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy Phase 3
Recruiting NCT05833633 - Study of Genotype and Phenotype Characterization in Duchenne Muscular Dystrophy With Small Mutations
Completed NCT05209087 - Effects of Parental Influence on Physical Activity Level and Participation in Children With Duchenne Muscular Dystrophy
Completed NCT03789734 - Safety Study of BLS-M22 in Healthy Volunteers Phase 1
Recruiting NCT05126758 - A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy Phase 3
Completed NCT00016653 - Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy Phase 2/Phase 3
Completed NCT03127241 - User-centred Assistive System for Arm Functions in Neuromuscular Subjects N/A
Completed NCT03490214 - Non-invasive Imaging of Muscle Structure in Duchenne Muscular Dystrophy Using Multispectral Optoacoustic Tomography N/A
Completed NCT03179631 - Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy Phase 3