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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

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Studies 62
Trials 100
Overview Studies Clinical Trials
Recruiting PHASE3 INTERVENTIONAL NCT05032326

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Follow-up study of the treated cohort
Type: DRUG
Description: follow-up study of the patients in the treated cohort: that have been included in the otbb3 study
Name: Follow-up study of the untreated cohort
Type: OTHER
Description: follow-up study of the patients in the untreated cohort: that have NOT been included in the otbb3 study

Primary Outcomes

Measure: Confirmation of the long term safety profile (1)
TimeFrame: 4 years
Description: The number of patients with adverse events (AEs)
Measure: Confirmation of the long term safety profile (2)
TimeFrame: 4 years
Description: The percentage of patients with adverse events (AEs)
Measure: Confirmation of the long term safety profile (3)
TimeFrame: 4 years
Description: Assessment in the treated cohort of the occurrence of the main comorbidities in Prader Willi Syndrome
Measure: Confirmation of the long term safety profile (4)
TimeFrame: 4 years
Description: Assessment in the treated cohort of: The occurrence of medications, surgery and rehabilitations by collecting type, age (years) at start and stop, dosing or frequency

Trial Information

NCT ID

NCT05032326

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

University Hospital, Toulouse

Last Updated

December 15, 2025