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RECRUITING
NCT05032326
PHASE3

Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

Summary

This study is a prospective, multicentre, interventional cohort study in children with Prader-Willi Syndrome (PWS) over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years. Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.

Official title: Long-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi Syndrome

Key Details

Gender

All

Age Range

12 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2021-09-07

Completion Date

2025-04-01

Last Updated

2024-04-30

Healthy Volunteers

No

Interventions

DRUG

Follow-up study of the treated cohort

follow-up study of the patients in the treated cohort: that have been included in the otbb3 study

OTHER

Follow-up study of the untreated cohort

follow-up study of the patients in the untreated cohort: that have NOT been included in the otbb3 study

Locations (12)

Hôpital Femme Mère Enfant

Bron, France

CHU Dijon Hôpital des Enfants

Dijon, France

CHU de Grenoble

Grenoble, France

Hôpital Jeanne de Flandre

Lille, France

Hôpital de la Timone Enfant

Marseille, France

CHU Nancy

Nancy, France

CHU Nantes

Nantes, France

Hôpital CHU-Lenval

Nice, France

Groupe Hospitalier Necker - Enfants Malades

Paris, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

Centre de réfrence Prader-Willi, Hospital of infants

Toulouse, France