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Completed

NCT Number: NCT01380964

Research of Biomarkers in Duchenne Muscular Dystrophy Patients

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.

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Key information

Conditions

Duchenne Muscular Dystrophy (DMD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

3 year–20 year

Sex eligibility

Male

Study type

Observational

Primary location

Institute of Myology

Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IBiSD aims to identify and validate new and disease-specific biomarkers.

    Time frame: End of study

    This study will establish the relevance of urinary and blood biomarkers for the diagnosis, follow-up and assessment of treatment response in patients with DMD (IBiSD1, 2 and 4). IBiSD will also attempt to establish the seroprevalence to the different strains of AAV in patients with DMD (IBiSD3).

Sponsors and collaborators

Lead sponsor

Genethon

Other

Collaborators

  • Institute of Myology

Registry information

Official study title

Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

Acronym: IBISD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2011
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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