NCT06877715 Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome
| NCT ID | NCT06877715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Prader-Willi Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2025-04-07 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prader-Willi Syndrome (PWS) is a rare neurodevelopmental disorder stemming from genetic damage in the 15q11-q13 region, leading to hypothalamic dysfunction. Individuals with PWS often exhibit social interaction challenges, intellectual deficits, significant eating disorders, mood disturbances, and sensory-related autistic features. Although PWS is recognized by DSM-5 as a genetic cause of Autism Spectrum Disorder (ASD), ASD diagnosis in PWS remains rare in France. The CASSPER study aims to investigate the distinct autistic and sensory profiles in children with PWS, also analyzing the potential impact of early oxytocin treatment on these manifestations, in line with recommendations for early and tailored intervention.
Eligibility Criteria
Inclusion Criteria: * Child with genetically confirmed PWS and identification of genetic subtype; * Child aged between 3 and 16 years; * Hospitalisation or multidisciplinary consultation planned for the child's routine follow-up at one of the investigating centres; * No parental/legal guardian objection. Exclusion Criteria: * Change in psychotropic treatment (start, change in dose or discontinuation) in the past 3 months; * Inability to provide clear information to parents/legal guardian; * Not covered by social security.
Contact & Investigator
Sophie Cabal
PRINCIPAL INVESTIGATOR
University Hospital of Toulouse
Frequently Asked Questions
Who can join the NCT06877715 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 16 Years, studying Prader-Willi Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06877715 currently recruiting?
Yes, NCT06877715 is actively recruiting participants. Contact the research team at algans.n@chu-toulouse.fr for enrollment information.
Where is the NCT06877715 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06877715 clinical trial?
NCT06877715 is sponsored by University Hospital, Toulouse. The principal investigator is Sophie Cabal at University Hospital of Toulouse. The trial plans to enroll 75 participants.