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

August 20, 2026 updated by: Soleno Therapeutics, Inc.

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Neurocrine Clinical Site
    • California
      • Los Angeles, California, United States, 90027
        • Neurocrine Clinical Site
      • Sacramento, California, United States, 95821
        • Neurocrine Clinical Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Neurocrine Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Neurocrine Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Neurocrine Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Neurocrine Clinical Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Neurocrine Clinical Site
      • Lansing, Michigan, United States, 48912
        • Neurocrine Clinical Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Neurocrine Clinical Site
      • Rochester, Minnesota, United States, 55905
        • Neurocrine Clinical Site
      • Saint Paul, Minnesota, United States, 55102
        • Neurocrine Clinical Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Neurocrine Clinical Site
    • New Jersey
      • Paterson, New Jersey, United States, 07503
        • Neurocrine Clinical Site
    • New York
      • Valley Stream, New York, United States, 11580
        • Neurocrine Clinical Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Neurocrine Clinical Site
      • Durham, North Carolina, United States, 27710
        • Neurocrine Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Neurocrine Clinical Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Neurocrine Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Neurocrine Clinical Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.

Description

Inclusion Criteria:

  • Patients currently receiving or initiating treatment with VYKAT XR, including patients who previously received DCCR or are transitioning from DCCR to VYKAT XR in the context of a prior DCCR clinical trial.
  • Patients and/or caregivers must provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
All patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR at the time of enrollment into this observational study, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Although the overall observational study is prospective, data from treatment prior to enrollment into the observational study, either from clinical practice or from DCCR clinical trials, may be collected retrospectively.
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.
Other Names:
  • PWS-VISTA (VYKAT XR Insights on Safety, Treatment characteristics, and Assessment of real-world outcomes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess safety profile of patients with PWS treated with VYKAT XR.
Time Frame: Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.
The safety profile will be based on adverse events, including nonserious adverse events, serious adverse events, and adverse events leading to discontinuation of VYKAT XR.
Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soleno Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 2, 2028

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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