NCT05032326

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-07
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2021-09-02
• Last updated: 2024-04-30

Locations

12 sites across 1 country: France

Regulatory

• FDA-regulated drug study