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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Soleno Therapeutics, Inc.
Study ID
NCT07450664
Status
Enrolling By Invitation

Conditions

  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VYKAT XR — DRUG
    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 Details

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

Key Dates

First listed
Mar 5, 2026
Start date
Nov 26, 2025
Status verified
Aug 2026
Primary completion
Mar 31, 2028
Completion
Mar 2, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.

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. ]

Locations (24)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SitePhoenixArizona85016-
Neurocrine Clinical SiteLos AngelesCalifornia90027-
Neurocrine Clinical SiteSacramentoCalifornia95821-
Neurocrine Clinical SiteAuroraColorado80045-
Neurocrine Clinical SiteAtlantaGeorgia30322-
Neurocrine Clinical SiteChicagoIllinois60611-
Neurocrine Clinical SiteIndianapolisIndiana46202-
Neurocrine Clinical SiteBostonMassachusetts02115-
Neurocrine Clinical SiteAnn ArborMichigan48109-
Neurocrine Clinical SiteLansingMichigan48912-
Neurocrine Clinical SiteMinneapolisMinnesota55454-
Neurocrine Clinical SiteRochesterMinnesota55905-
Neurocrine Clinical SiteSaint PaulMinnesota55102-
Neurocrine Clinical SiteKansas CityMissouri64111-
Neurocrine Clinical SitePatersonNew Jersey07503-
Neurocrine Clinical SiteValley StreamNew York11580-
Neurocrine Clinical SiteChapel HillNorth Carolina27514-
Neurocrine Clinical SiteDurhamNorth Carolina27710-
Neurocrine Clinical SitePortlandOregon97227-
Neurocrine Clinical SiteNashvilleTennessee37232-
Neurocrine Clinical SiteDallasTexas75231-
Neurocrine Clinical SiteHoustonTexas77030-
Neurocrine Clinical SiteSalt Lake CityUtah84108-
Neurocrine Clinical SiteSeattleWashington98105-

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Neurocrine Clinical Site· Phoenix, AZNeurocrine Clinical Site· Los Angeles, CANeurocrine Clinical Site· Sacramento, CANeurocrine Clinical Site· Aurora, CONeurocrine Clinical Site· Atlanta, GANeurocrine Clinical Site· Chicago, IL

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