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NCT07450664Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
200 (estimated)
First submitted
9 Feb 2026
Start date
26 Nov 2025
Primary completion date
Mar 2028
Lead sponsor
Soleno Therapeutics, Inc.
NCT number
NCT07450664

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 26 Nov 2025 to the primary completion date, Mar 2028
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Ann ArborUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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BostonUnited StatesUnknown status
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Chapel HillUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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GainesvilleUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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LansingUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MinneapolisUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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PatersonUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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Saint PaulUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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Valley StreamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.