Register of Patients With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829684
• Other study ID #: 07 315 03
• Status: Recruiting
• Start date: March 2009
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: TAUBER Maité, MD PhD
• Email: tauber.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments. The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent. Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all subjects with a Prader-Willi Syndrome Exclusion Criteria: -

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

Other:
• Data collection
This register will follow the evolution of the clinical practices and their consequences in the health of the patients, in all regions of France in order to have a national register. for Children and adults.

Locations

Country	Name	City	State
France	University Hospital of Children	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Pacoricona Alfaro DL, Lemoine P, Ehlinger V, Molinas C, Diene G, Valette M, Pinto G, Coupaye M, Poitou-Bernert C, Thuilleaux D, Arnaud C, Tauber M. Causes of death in Prader-Willi syndrome: lessons from 11 years' experience of a national reference center. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	collect data about patients	Circumstances of diagnosis, genetic diagnosis, modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data	Baseline
Secondary	collect data about patients	modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data	During 10 years at least