Actively Recruiting

Age: 4Years - 9Years
MALE
NCT03882827

Natural History of Duchenne Muscular Dystrophy

Led by Genethon · Updated on 2026-02-12

220

Participants Needed

15

Research Sites

510 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Baseline Study on Duchenne Muscular Dystrophy (DMD) in view to collect data on the natural disease course in a cohort in young male subjects aged from 4 to 9 Years over a period of 6 to 36 months using disease appropriate evaluations.

CONDITIONS

Official Title

Natural History of Duchenne Muscular Dystrophy

Who Can Participate

Age: 4Years - 9Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male
  • Aged 4 to 9 years inclusive
  • Body weight or BMI at or below the 95th percentile based on local validated scales
  • Confirmed diagnosis of Duchenne Muscular Dystrophy by gene testing with detailed genotyping
  • Able to achieve at screening and inclusion visits: NSAA scale >18 or 616 if between 4 and <5 years old, Gowers test 67 seconds, and/or 6-Minute Walk Test distance 350 meters at inclusion
  • Ongoing or planned corticosteroid therapy according to standard care before screening
  • Signed informed consent by parent(s) or legal guardian
  • Affiliated with or beneficiary of a health care scheme as per local regulations
Not Eligible

You will not qualify if you...

  • Cardiomyopathy with Left Ventricular Ejection Fraction below 55%
  • Need for daytime or nighttime respiratory ventilation support
  • Any co-morbidities or surgeries that may affect DMD progression or study evaluations
  • Inability to cooperate with muscle testing
  • Presence of metal implants in areas of interest for MRI
  • Unwillingness or inability to comply with study procedures
  • Participation in another investigational medicinal product trial within 3 months or IMP washout
  • Previous gene therapy treatment for DMD, including AAV-mediated gene transfer or gene editing
  • Recent exon skipping drug use within 5 half-lives prior to screening
  • Concurrent participation in any other interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Centre Hospitalier Universitaire Brugmann

Brussels, Belgium, 1020

Actively Recruiting

2

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

3

CHR Hôpital de la Citadelle

Liège, Belgium, 4000

Not Yet Recruiting

4

University Hospital of Bordeaux

Bordeaux, France, 33076

Actively Recruiting

5

Brest University Hospital Centre

Brest, France, 29609

Actively Recruiting

6

Hopital Femme Mere Enfant

Bron, France, 69677

Actively Recruiting

7

CHU Lille

Lille, France, 59000

Actively Recruiting

8

Hopital la Timone Enfants

Marseille, France, 13385

Actively Recruiting

9

Centre Hospitalier Universitaire - Hôpital Gui de Chauliac

Montpellier, France, 34295

Not Yet Recruiting

10

Hôpital Armand Trousseau

Paris, France, 75011

Actively Recruiting

11

Hôpital Hautepierre

Strasbourg, France, 67000

Actively Recruiting

12

Hospital Sant Joan de Deu Esplugues de Llobregat

Esplugues de Llobregat, Spain, 8950

Actively Recruiting

13

Hospital La Fe de Valencia

Valencia, Spain, 46026

Active, Not Recruiting

14

Great Ormond Street Hospital & University College London Hospital

London, United Kingdom, WC1N 1EH

Actively Recruiting

15

Institute of Genetic Medicine

Newcastle, United Kingdom

Actively Recruiting

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Research Team

F

Francesco MUNTONI, Pr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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