Phase
Condition
Hypogonadism
Severe Short Stature
Treatment
N/AClinical Study ID
Ages 7-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Genetically-confirmed Prader-Willi syndrome
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) ofparticipant); provide voluntary, written assent (participants, as appropriate)
- PWS Nutritional Phase 3 (hyperphagic, rarely feels full)
Exclusion
Exclusion Criteria:
- Living in a group home
- Genetically diagnosed Schaaf-Yang syndrome or other genetic, hormonal, or chromosomalcognitive impairment
- New food-related interventions, including environment or dietary restrictions, within 1 month of screening
- Dose of any allowed chronic concomitant medications or supplements that have not beenstable for ≥3 months prior to the study or is not expected to remain stable whileparticipating in the study; adjustments in growth hormone dose ≤10% are notexclusionary
- Presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma
- More than 3 episodes of sinusitis in the 12 months prior to Screening Visit orpresence of nasal diseases that may affect deposition of intranasal medication
- Unwilling to abstain from nasal saline, other nasal irrigation, or other intranasalmedications for 2 weeks prior to the Baseline visit and during the 8-week,placebo-controlled period of the study
- Use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 monthsprior to screening
- Participation in an interventional research study involving another investigationalmedication or device in the 6 months prior to screening or during the study
- Based on the judgment of the Investigator, is unsuitable for the study for any reason,including but not limited to unstable medical condition, inability to comply with theprotocol, or other risk to subject or to the integrity of the study
Study Design
Study Description
Connect with a study center
Sydney Children's Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
The Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaSite Not Available
Queensland Children's Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
University of Alberta
Edmonton, Alberta T6G 2E1
CanadaSite Not Available
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3V4
CanadaSite Not Available
Toronto Hospital for Sick Kids
Toronto, Ontario M5G 1X8
CanadaSite Not Available
CHU Ste Justine
Montréal, Quebec H3T 1C5
CanadaSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Phoenix Children's Hospital
Phoenix, Arizona 85006
United StatesSite Not Available
Children's Hospital of Los Angeles (USC)
Los Angeles, California 90027
United StatesSite Not Available
Stanford Children's Health
Palo Alto, California 94304
United StatesSite Not Available
Rady Children's Hospital San Diego
San Diego, California 92123
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's National
Washington, District of Columbia 20010
United StatesSite Not Available
University of Florida
Gainesville, Florida 32608
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Kansas University Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Harvard Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota 55102
United StatesSite Not Available
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri 63104
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Tulsa, Oklahoma 74135
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Vanderbilt University School of Medicine
Nashville, Tennessee 37212
United StatesSite Not Available
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
Children's Hospital of San Antonio
San Antonio, Texas 78207
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
MultiCare Health System
Tacoma, Washington 98405
United StatesSite Not Available
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