ClinicalTrials.gov record NCT07450664

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age4 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study collecting safety and clinical data from people with Prader‑Willi syndrome who are starting or already taking VYKAT XR. Data from before enrollment may be collected retrospectively, including from prior DCCR trials. Clinical care is provided by each patient's doctor; the study does not provide experimental treatment.

What it is studying. The study aims to gather more evidence about the safety profile, clinical characteristics, and clinical outcomes of patients with PWS treated with VYKAT XR. Safety assessment is based on adverse events collected from first dose through last contact.

What the researchers hope to learn. To describe the safety profile of VYKAT XR in real-world use (including nonserious and serious adverse events and events leading to discontinuation), and to characterize clinical features and outcomes of patients with PWS treated with VYKAT XR.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: VYKAT XR

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Provide written informed consent and allow the study team to collect medical information about their VYKAT XR treatment. The study will collect safety and clinical outcome data while participants are on VYKAT XR and may also collect earlier treatment data from medical records or prior DCCR trials. Clinical care is not mandated by the study—participants receive commercial VYKAT XR prescribed by their own physicians and will not receive an experimental treatment from the Sponsor. Adverse events will be recorded from each patient’s first VYKAT XR dose until the last contact.

How the study is structured. A prospective, observational cohort study. Participants are people with PWS who are initiating or already receiving commercially prescribed VYKAT XR; no experimental drug is given by the sponsor. The study collects routine clinical data and may also collect earlier treatment data retrospectively (for example, from prior DCCR trials). Clinical care is not dictated by the study protocol.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 26, 2025
Primary completion: March 2028 (estimated)
Study completion: Mar 2, 2028 (estimated)
Target enrollment: 200 participants (estimated)
Last updated on registry: Oct 8, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Soleno Therapeutics, Inc.

Participating sites (24)

Soleno Clinical Site
Phoenix, Arizona, 85016 · United States
Soleno Clinical Site
Los Angeles, California, 90027 · United States
Soleno Clinical Site
Sacramento, California, 95821 · United States
Soleno Clinical Site
Aurora, Colorado, 80045 · United States
Soleno Clinical Site
Atlanta, Georgia, 30322 · United States
Soleno Clinical Site
Chicago, Illinois, 60611 · United States
Soleno Clinical Site
Indianapolis, Indiana, 46202 · United States
Soleno Clinical Site
Boston, Massachusetts, 02115 · United States
Soleno Clinical Site
Ann Arbor, Michigan, 48109 · United States
Soleno Clinical Site
Lansing, Michigan, 48912 · United States

Terms used on this page · explanations by MedicalUpdates.ai

clinical trial: A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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