Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2018
CompletedResults Posted
Study results publicly available
June 25, 2019
CompletedMarch 26, 2020
March 1, 2020
5 months
August 7, 2017
January 2, 2019
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
Swallow study Overall improvement
baseline to day 5
Study Arms (2)
Intranasal oxytocin
ACTIVE COMPARATORIntervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
IN-placebo
PLACEBO COMPARATORIntervention: 4 IU/day of placebo via nasal spray device each morning.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Prader-Willi Syndrome Associationcollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Short study with small number of participants
Results Point of Contact
- Title
- Jennifer Miller, MD
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Miller, MD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2017
First Posted
August 10, 2017
Study Start
August 1, 2017
Primary Completion
January 4, 2018
Study Completion
January 4, 2018
Last Updated
March 26, 2020
Results First Posted
June 25, 2019
Record last verified: 2020-03