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ClinicalTrials.gov ID

NCT05032326

Lead Sponsor

University Hospital, ToulouseOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

80Estimated

Last Update Posted

Apr 30, 2024Actual

Start Date

Sep 7, 2021Actual

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Apr 1, 2025Estimated

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

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.

• Prader-Willi Syndrome

• Follow-up study of the treated cohort
• Follow-up study of the untreated cohort

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Male or female child with a genetically confirmed diagnosis of PWS (patients can be enrolled if the genetic subtype is not available at inclusion, but the genetic subtype needs to be confirmed during the study);
2. The parents (or legal representative) must have signed the consent form;
3. Treated cohort: the child participated in the OTBB3 study and is aged 16±4 months at inclusion,
4. Untreated cohort: the child has never received OT, is aged 30±6 months at inclusion (in order to maximise the number of children in the untreated cohort) and is followed in France.

Exclusion Criteria:

1. Administrative problems:

   1. Inability for the parents (or legal representative) to understand/fulfil study requirements;
   2. No coverage by a social security regime;

2. Refusal of parents (or legal representative) to sign the consent form;

Primary Purpose

Other

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, ToulouseOTHER

c.legagneur@chru-nancy.fr

sabine.baron@chu-nantes.fr

Marie-beatrice.SAADE@chu-rennes.fr

mireille.castanet@chu-rouen.fr