EichorEICHOR
Study identifier: NCT03917719 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: TerminatedGalaxyDMD

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

Condition: Duchenne Muscular Dystrophy  ·  Sponsor: Catabasis Pharmaceuticals

PhasePhase 3
Planned participants130
Who can joinMale, 4 Years to 12 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where23 locations · 6 countries
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

About this study

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

For Patients who Completed CAT-1004-201 or CAT-1004-301: Inclusion Criteria: * Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements * Completion of either CAT-1004-201 or CAT-1004-301 Exclusion Criteria: * In the Investigator's opinion, unwilling or unable for any reason to complete all study assessments and laboratory tests and comply with scheduled visits, administration of drug, and all other study procedures For Siblings of Patients who Completed CAT-1004-201 or CAT-1004-301: Inclusion Criteria: * Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements * A sibling of a patient who completed either CAT-1004-201 or CAT-1004-301 * Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase (CK) and documentation of mutation(s) in the dystrophin gene known to be associated with a DMD phenotype * Followed by a doctor or medical professional who coordinates Duchenne care on a regular basis and willingness to disclose patient's study participation with medical professionals Exclusion Criteria: * Use of oral corticosteroids at screening; use of inhaled, intranasal, and topical corticosteroids is permitted * Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4 weeks. Exception: Patients who are currently on or plan to initiate treatment with approved oligonucleotide exon-skipping therapies, and expected to continue treatment throughout the study, will be eligible * Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy, anticoagulants, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil, pimozide, quinidine, sirolimus or tacrolimus * Use of human growth hormone within 3 months prior to Day 1 * Other prior or ongoing significant medical conditions

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (23)

UC DavisSacramento, California, United States
Rare Disease Research, LLCAtlanta, Georgia, United States
University of Iowa Children's HospitalIowa City, Iowa, United States
University of Kansas Medical CenterFairway, Kansas, United States
Kennedy Krieger InstituteBaltimore, Maryland, United States
Johns Hopkins School of MedicineBaltimore, Maryland, United States
Boston Children's HospitalBoston, Massachusetts, United States
University of MichiganAnn Arbor, Michigan, United States
Las Vegas ClinicLas Vegas, Nevada, United States
Shriners Hospital for ChildrenPortland, Oregon, United States
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United States
Vanderbilt University Medical CenterNashville, Tennessee, United States

+ 11 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

SacramentoAtlantaIowa CityFairway

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.

Look up another condition
Look up another city
Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →