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National Multicentre Study of the Natural History of Acid Sphingo-myelinase Deficiency in Adults and Children

Study acronym: FASMD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Wladimir MAUHIN, Dr

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of May 15, 2025 to May 2, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 1 to 4
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to describe the natural history of ASMD in adult and paediatric patients with or without specific treatment in order to assess the impact of the disease on their daily lives and quality of life. The population concerned corresponds to patients aged at least 2 years, with a definite diagnosis of ASMD as determined by a confirmed low acid sphingomyelinase assay and who have not expressed their opposition to participating in this research (patients and/or parental authority).
Trial Details
NCT Number NCT06985212
Lead Sponsor Wladimir MAUHIN, Dr
Collaborators: Beaujon Hospital, University Hospital, Montpellier, Centre Hospitalier Saint Joseph Saint Luc de Lyon, Bichat Hospital, Versailles Hospital, University Hospital, Bordeaux, Hôpital de la Timone (MARSEILLE), Hôpital Claude-Huriez, Hospices Civils de Lyon, Hôpital Armand Trousseau, Centre Hospitalier de Cornouaille, Nantes University Hospital, University Hospital, Angers, Hospital BLOIS, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Eure-Seine, University Hospital, Orléans, University Hospital, Toulouse, APHM - Nord, Henri Mondor University Hospital, Hôpital Européen Marseille, CH Henri Mondor (Aurillac), University Hospital, Clermont-Ferrand, Centre Hospitalier Universitaire de Saint Etienne, Hôpital Pellegrin, CHU Bordeau, Reims University hospital, Hospital Avicenne, University Hospital, Strasbourg, Hôpital Necker-Enfants Malades
Conditions
(from sponsor)		 Acid Sphingomyelinase Deficiency (ASMD), Niemann Pick Disease
Related terms Niemann-Pick Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov