An observational study in Prader-Willi Syndrome, sponsored by Soleno Therapeutics, Inc.. Enrolling by invitation at 25 sites in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Soleno Therapeutics, Inc. (part of Neurocrine Biosciences) · Observational
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
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.
144 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
This study's planned enrollment of 200 is above the median of 51 across 36 observational studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →Soleno Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
First submitted before Soleno Therapeutics, Inc. became part of Neurocrine Biosciences.
Counted across the registry records on this site, refreshed daily.
This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: PWS-VISTA (VYKAT XR Insights on Safety, Treatment characteristics, and Assessment of real-world outcomes)
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Mar 2028, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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