Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245762
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Prader-Willi Syndrome Association
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Oxytocin Drug: Placebo Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes 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.
Primary Purpose: Basic Science
Official Title: Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : January 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Intranasal oxytocin
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
Drug: Oxytocin
4 IU/day of oxytocin administered via nasal spray device each morning.
Other Name: Syntocinon

Placebo Comparator: IN-placebo
Intervention: 4 IU/day of placebo via nasal spray device each morning.
Drug: Placebo
4 IU/day of placebo administered via nasal spray device each morning
Other Name: Saline




Primary Outcome Measures :
  1. Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a [ Time Frame: baseline to day 5 ]
    Swallow study Overall improvement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245762


Locations
Layout table for location information
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Prader-Willi Syndrome Association
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Miller, MD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03245762     History of Changes
Other Study ID Numbers: IRB201700423 -A
OCR16237 ( Other Identifier: University of Florida )
First Posted: August 10, 2017    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs