Research of Biomarkers in Duchenne Muscular Dystrophy Patients (IBISD)

Genethon

Status: Completed

Conditions: Duchenne Muscular Dystrophy (DMD)

Study type: Observational

Funder types: Other

Identifiers

NCT01380964

GEE006.10

Details and patient eligibility

About

The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.

Enrollment: 220 patients

Sex: Male

Ages: 3 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• FOR PATIENTS:
• Diagnosis of DMD confirmed by genetic testing
• Age over 3 years
• Weight over 15 kg
• Informed consent signed
• FOR CONTROLS:
• Age over 3 years
• Male gender
• Weight over 15 kg
• Subjects with national health insurance coverage
• Informed consent signed
• Nonacute or chronic muscular, allergic, infectious, endocrine or inflammatory disorder in the 3 weeks preceding inclusion

Exclusion criteria

• FOR PATIENTS:
• Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test
• Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed
• Mental retardation or autism
• Vaccination or treatment with immunoglobulins within the three months preceding inclusion
• FOR CONTROLS:
• Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test
• Vaccination or treatment with immunoglobulins within the three months preceding inclusion

Trial design

220 participants in 2 patient groups

DMD patients

Description:

DMD Patients

Control patients

Description:

Control patients