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

Part of paid clinical trials in Los Angeles, California.

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

Start date
Nov 26, 2025
Status verified
May 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 (15)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Emory Children's CenterAtlantaGeorgia30322-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Indiana UniversityIndianapolisIndiana46202-
University of Michigan Medical CenterAnn ArborMichigan48109-
Sparrow Clinical Research InstituteLansingMichigan48912-
Children's MinnesotaSaint PaulMinnesota55102-
Children's Mercy HospitalKansas CityMissouri64111-
Saint Josephs HealthPatersonNew Jersey07503-
Long Island Jewish Valley StreamValley StreamNew York11580-
UNC HospitalsChapel HillNorth Carolina27514-
Legacy Emanuel Medical CenterPortlandOregon97227-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Children's Medical Center DallasDallasTexas75231-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAEmory Children's Center· Atlanta, GANorthwestern University Feinberg School of Medicine· Chicago, ILIndiana University· Indianapolis, INUniversity of Michigan Medical Center· Ann Arbor, MISparrow Clinical Research Institute· Lansing, MI

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