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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 (OTBB3 FOLLOW-UP)
EU CTIS ID: 2024-517925-25-00
What this study is testing
The primary objective of this study will be to confirm the long-term safety profile, including the associated main comorbidities, in all children with PWS who have been treated in the OTBB3 study.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female child with a genetically confirmed diagnosis of PWS ; 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. Inclusion visit will be performed considering the next routine consultation. 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. Inclusion visit will be performed considering the next routine consultation.
- 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. Inclusion visit will be performed considering the next routine consultation.
You likely can't join if
- 1. Administrative problems: a. Inability for the parents (or legal representative) to understand/fulfil study requirements; b. No coverage by a social security regime;
- 2. Refusal of parents (or legal representative) to sign the consent form;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.