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ENROLLING BY INVITATION
NCT07450664

Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome

Sponsor: Soleno Therapeutics, Inc.

View on ClinicalTrials.gov

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

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

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 (24)

Neurocrine Clinical Site

Phoenix, Arizona, United States

Neurocrine Clinical Site

Los Angeles, California, United States

Neurocrine Clinical Site

Sacramento, California, United States

Neurocrine Clinical Site

Aurora, Colorado, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Chicago, Illinois, United States

Neurocrine Clinical Site

Indianapolis, Indiana, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Ann Arbor, Michigan, United States

Neurocrine Clinical Site

Lansing, Michigan, United States

Neurocrine Clinical Site

Minneapolis, Minnesota, United States

Neurocrine Clinical Site

Rochester, Minnesota, United States

Neurocrine Clinical Site

Saint Paul, Minnesota, United States

Neurocrine Clinical Site

Kansas City, Missouri, United States

Neurocrine Clinical Site

Paterson, New Jersey, United States

Neurocrine Clinical Site

Valley Stream, New York, United States

Neurocrine Clinical Site

Chapel Hill, North Carolina, United States

Neurocrine Clinical Site

Durham, North Carolina, United States

Neurocrine Clinical Site

Portland, Oregon, United States

Neurocrine Clinical Site

Nashville, Tennessee, United States

Neurocrine Clinical Site

Dallas, Texas, United States

Neurocrine Clinical Site

Houston, Texas, United States

Neurocrine Clinical Site

Salt Lake City, Utah, United States

Neurocrine Clinical Site

Seattle, Washington, United States