Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:

Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245762
• Other study ID #: IRB201700423 -A
• Secondary ID: OCR16237
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2017
• Est. completion date: January 4, 2018

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

Description:

The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (OT) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding.

Study Hypothesis 2: The Study team hypothesize that replacing OT in infants and children with PWS will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI

2. Physical exam and laboratory results that are within the normal range.

3. Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.

2. Prior chronic treatment with oxytocin.

3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• Oxytocin
4 IU/day of oxytocin administered via nasal spray device each morning.
• Placebo
4 IU/day of placebo administered via nasal spray device each morning

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Prader-Willi Syndrome Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a	Swallow study Overall improvement	baseline to day 5