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Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Sponsor: Soleno Therapeutics, Inc.
Summary
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Official title: An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2025-11-26
Completion Date
2028-03-02
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
VYKAT XR
All prospective treatment in this protocol will be commercial VYKAT XR prescribed to patients by their physicians in addition to their standard of care; patients will not receive experimental intervention or treatment from the Sponsor as part of their participation in this study.
Locations (15)
Children's Hospital Los Angeles
Los Angeles, California, United States
Emory Children's Center
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Saint Josephs Health
Paterson, New Jersey, United States
Long Island Jewish Valley Stream
Valley Stream, New York, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Legacy Emanuel Medical Center
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States