Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
NCT07450664 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-05-19
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.
Conditions
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.
Sponsors & Collaborators
-
Soleno Therapeutics, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 4 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-26
- Primary Completion
- 2028-03-31
- Completion
- 2028-03-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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