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Clinical Trials/EUCTR2019-002385-12-DE
EUCTR2019-002385-12-DE
Active, not recruiting
Phase 1

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

niversity Hospital of Toulouse0 sites48 target enrollmentApril 21, 2021
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital of Toulouse
Enrollment
48
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 21, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital of Toulouse

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 amenorrhea, corrected age will be applied)
  • •\- Signed informed consent obtained from the parents/holders of parental authority
  • •\- Parents willing and able to comply with all study procedures.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 48
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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 with hypokaliema
  • •\- 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 the excipients of the product
  • •\- Neonate or infant participating simultaneously in another interventional study.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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
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OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEPrader-Willi SyndromTherapeutic area: Diseases [C] - Hormonal diseases [C19]
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OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME
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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)Prader-Willi-syndromerare gentic disease100292991002160510028920
NL-OMON55101CHU de TOULOUSE5
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