Trials / Completed
CompletedNCT05298085
Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome
Effect of Intranasal Oxytocin on Dysphagia Related to Oropharyngo-oesophageal Dysmotility in Children and Adolescents With Prader-Willi Syndrome: a Phase 2B Study
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS). This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin nasal spray | Study treatment will be administered intranasally daily for 12 weeks. The daily dose of OT will be adapted according to age at the beginning of the study |
| DRUG | Placebo | Study treatment will be administered intranasally daily for 12 weeks. |
Timeline
- Start date
- 2022-04-05
- Primary completion
- 2023-04-11
- Completion
- 2023-04-11
- First posted
- 2022-03-28
- Last updated
- 2023-06-01
Locations
4 sites across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05298085. Inclusion in this directory is not an endorsement.