Prader-Willi SyndromeNCT07450664
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome, run by Soleno Therapeutics, Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- VYKAT XR
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- 26 Nov 2025to 2 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
United States25 sites
Soleno Clinical Site
Ann Arbor, Michigan, 48109
Soleno Clinical Site
Atlanta, Georgia, 30322
Soleno Clinical Site
Aurora, Colorado, 80045
Soleno Clinical Site
Boston, Massachusetts, 02115
Soleno Clinical Site
Chapel Hill, North Carolina, 27514
Soleno Clinical Site
Chicago, Illinois, 60611
Soleno Clinical Site
Dallas, Texas, 75231
Soleno Clinical Site
Durham, North Carolina, 27710
Soleno Clinical Site
Gainesville, Florida, 32608
Soleno Clinical Site
Houston, Texas, 77030
Soleno Clinical Site
Indianapolis, Indiana, 46202
Soleno Clinical Site
Kansas City, Missouri, 64111
Soleno Clinical Site
Lansing, Michigan, 48912
Soleno Clinical Site
Los Angeles, California, 90027
Soleno Clinical Site
Minneapolis, Minnesota, 55454
Soleno Clinical Site
Nashville, Tennessee, 37232
Soleno Clinical Site
Paterson, New Jersey, 07503
Soleno Clinical Site
Phoenix, Arizona, 85016
Soleno Clinical Site
Portland, Oregon, 97227
Soleno Clinical Site
Rochester, Minnesota, 55905
Soleno Clinical Site
Sacramento, California, 95821
Soleno Clinical Site
Saint Paul, Minnesota, 55102
Soleno Clinical Site
Salt Lake City, Utah, 84108
Soleno Clinical Site
Seattle, Washington, 98105
Soleno Clinical Site
Valley Stream, New York, 11580
About this study
Official title: 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.
Read the 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
- Being tested
- VYKAT XR
- Keywords
- Prader-Willi Syndrome, PWS
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VYKAT XRDrug
Also called PWS-VISTA (VYKAT XR Insights on Safety, Treatment characteristics, and Assessment of real-world outcomes)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: VYKAT XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety profile of patients with PWS treated with VYKAT XR.
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.
Measured: Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start26 Nov 2025
- Primary completionMar 2028 (estimated)
- Study completion2 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soleno Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450664
- Sponsor's protocol ID
- C623
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)
- ClinicalTrials.gov ID
- NCT07450664
- Acronym / sponsor ID
- C623
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi Syndrome, PWS
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Soleno Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 2 Mar 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PWS who are currently receiving or initiating treatment with VYKAT XR. | – | Drug: VYKAT XRAll 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VYKAT XRAlso: PWS-VISTA (VYKAT XR Insights on Safety, Treatment characteristics, and Assessment of real-world outcomes)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. | Drug | Patients with PWS who are currently receiving or initiating treatment with VYKAT XR. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by Soleno Therapeutics, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.