NCT07450664

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

An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Soleno Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Data from treatment prior to enrollment either from clinical practice or from previous DCCR clinical trials may be collected retrospectively. Clinical care will not be mandated by the protocol.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-03-01
• Completion: 2028-03-02
• First posted: 2026-03-05
• Last updated: 2026-04-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study