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Enrolling by invitation No phase listed Observational

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

ClinicalTrials.gov ID: NCT07450664

Public ClinicalTrials.gov record NCT07450664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.

Study identification

NCT ID
NCT07450664
Recruitment status
Enrolling by invitation
Study type
Observational
Phase
Not listed
Lead sponsor
Soleno Therapeutics, Inc.
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
4 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 26, 2025 (Actual)
Primary completion
Mar 2028 (Estimated)
Completion
Mar 2, 2028 (Estimated)
Last update posted
Oct 14, 2026

2025 – 2028

United States locations

U.S. sites
25
U.S. states
19
U.S. cities
25
Facility City State ZIP Site status
Soleno Clinical Site Phoenix Arizona 85016 —
Soleno Clinical Site Los Angeles California 90027 —
Soleno Clinical Site Sacramento California 95821 —
Soleno Clinical Site Aurora Colorado 80045 —
Soleno Clinical Site Gainesville Florida 32608 —
Soleno Clinical Site Atlanta Georgia 30322 —
Soleno Clinical Site Chicago Illinois 60611 —
Soleno Clinical Site Indianapolis Indiana 46202 —
Soleno Clinical Site Boston Massachusetts 02115 —
Soleno Clinical Site Ann Arbor Michigan 48109 —
Soleno Clinical Site Lansing Michigan 48912 —
Soleno Clinical Site Minneapolis Minnesota 55454 —
Soleno Clinical Site Rochester Minnesota 55905 —
Soleno Clinical Site Saint Paul Minnesota 55102 —
Soleno Clinical Site Kansas City Missouri 64111 —
Soleno Clinical Site Paterson New Jersey 07503 —
Soleno Clinical Site Valley Stream New York 11580 —
Soleno Clinical Site Chapel Hill North Carolina 27514 —
Soleno Clinical Site Durham North Carolina 27710 —
Soleno Clinical Site Portland Oregon 97227 —
Soleno Clinical Site Nashville Tennessee 37232 —
Soleno Clinical Site Dallas Texas 75231 —
Soleno Clinical Site Houston Texas 77030 —
Soleno Clinical Site Salt Lake City Utah 84108 —
Soleno Clinical Site Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07450664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 14, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07450664 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →