Trials / Completed
CompletedNCT04283578
Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome
Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- 1 Day – 92 Days
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OT | One group will receive OT for 4 weeks, then placebo or OT for 8 weeks |
| DRUG | Placebo comparator | One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks. |
Timeline
- Start date
- 2020-03-10
- Primary completion
- 2021-10-16
- Completion
- 2022-03-14
- First posted
- 2020-02-25
- Last updated
- 2023-06-01
Locations
7 sites across 3 countries: Belgium, France, Germany
Source: ClinicalTrials.gov record NCT04283578. Inclusion in this directory is not an endorsement.