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Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Primary Purpose

Prader-Willi Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prader-Willi Syndrome

Eligibility Criteria

1 Week - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intranasal oxytocin

IN-placebo

Arm Description

Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.

Intervention: 4 IU/day of placebo via nasal spray device each morning.

Outcomes

Primary Outcome Measures

Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
Swallow study Overall improvement

Secondary Outcome Measures

Full Information

First Posted
August 7, 2017
Last Updated
March 24, 2020
Sponsor
University of Florida
Collaborators
Prader-Willi Syndrome Association
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1. Study Identification

Unique Protocol Identification Number
NCT03245762
Brief Title
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Official Title
Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
January 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Prader-Willi Syndrome Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
This will be a double-blinded study, as no studies to date have compared this treatment in infants with placebo. Board-certified speech and language pathologist who will be blinded to the treatment arm of each patient.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal oxytocin
Arm Type
Active Comparator
Arm Description
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
Arm Title
IN-placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: 4 IU/day of placebo via nasal spray device each morning.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
4 IU/day of oxytocin administered via nasal spray device each morning.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
4 IU/day of placebo administered via nasal spray device each morning
Primary Outcome Measure Information:
Title
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
Description
Swallow study Overall improvement
Time Frame
baseline to day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI Physical exam and laboratory results that are within the normal range. Presence of a parent/caregiver/guardian that is able to consent for their participation. Exclusion Criteria: Exposure to any investigational agent in the 30 days prior to randomization. Prior chronic treatment with oxytocin. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Miller, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

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