NL-OMON55101
Withdrawn
Phase 3
Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome: a study of the safety and efficacy on oral and social skills and, feeding behavior of intranasal administrations of oxytocin vs. placebo (phase iii clinical trial) - OTBB3
CHU de TOULOUSE0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prader-Willi-syndrome
- Sponsor
- CHU de TOULOUSE
- Enrollment
- 5
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female neonate or infant, with PWS genetically confirmed
- •\- Age \<92 days (plus a tolerance of up to 8 days maximum) (for preterm infants,
- •born before 37 weeks, corrected age will be applied)
- •\- Signed informed consent obtained from the parents/holders of parental
- •\- Parents willing and able to comply with all study procedures.
Exclusion Criteria
- •\- Neonate or infant admitted to the emergency care unit for ongoing
- •life\-threatening comorbidities like severe respiratory, cardiovascular or
- •neurological abnormalities
- •\- Neonate or infant with prolongation of the QT interval
- •\- Neonate or infant without medical insurance
- •\- Neonates or infants whose parents\* situations may jeopardize the
- •interpretation of the results
- •\- Neonate or infant with known hypersensitivity to oxytocin or the excipients
- •of the product
- •\-Neonate or infant with concomitant treatment prolonging QT interval (cf. annex
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndromeEUCTR2019-002385-12-NLniversity Hospital of Toulouse48
Active, not recruiting
Phase 1
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEEUCTR2019-002385-12-DEniversity Hospital of Toulouse48
Active, not recruiting
Phase 1
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEPrader-Willi SyndromTherapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2019-002385-12-ITniversity Hospital Toulouse48
Active, not recruiting
Phase 1
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEPrader-Willi SyndromTherapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2019-002385-12-FRniversity Hospital of Toulouse48
Active, not recruiting
Phase 1
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEEUCTR2019-002385-12-BEniversity Hospital of Toulouse48