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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517925-25-00

Acronym

RC31/20/0421

Enrollment

Registered

2024-12-17

Start date

Unknown

Completion date

2025-04-29

Last updated

2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prader-willi syndrome

Brief summary

The number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs);, The occurrence of the main comorbidities, The occurrence of medications, surgery and rehabilitations by collecting type, age at start and stop, dosing or frequency.

Interventions

DRUGOtwillo 44.44 IU/mL

DRUGnasal spray solution

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs);, The occurrence of the main comorbidities, The occurrence of medications, surgery and rehabilitations by collecting type, age at start and stop, dosing or frequency.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026