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New drug under observation for rare genetic disorder

NCT ID NCT07450664

Disease control Sponsor: Soleno Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study follows about 200 people with Prader-Willi syndrome who are taking or starting VYKAT XR. Researchers will track side effects and how the drug affects their health over time. The goal is to gather more safety information, not to test if the drug cures the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Prader-Willi syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prader-Willi syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Phoenix, Arizona, 85016, United States

  • Neurocrine Clinical Site

    Los Angeles, California, 90027, United States

  • Neurocrine Clinical Site

    Sacramento, California, 95821, United States

  • Neurocrine Clinical Site

    Aurora, Colorado, 80045, United States

  • Neurocrine Clinical Site

    Atlanta, Georgia, 30322, United States

  • Neurocrine Clinical Site

    Chicago, Illinois, 60611, United States

  • Neurocrine Clinical Site

    Indianapolis, Indiana, 46202, United States

  • Neurocrine Clinical Site

    Boston, Massachusetts, 02115, United States

  • Neurocrine Clinical Site

    Ann Arbor, Michigan, 48109, United States

  • Neurocrine Clinical Site

    Lansing, Michigan, 48912, United States

  • Neurocrine Clinical Site

    Minneapolis, Minnesota, 55454, United States

  • Neurocrine Clinical Site

    Rochester, Minnesota, 55905, United States

  • Neurocrine Clinical Site

    Saint Paul, Minnesota, 55102, United States

  • Neurocrine Clinical Site

    Kansas City, Missouri, 64111, United States

  • Neurocrine Clinical Site

    Paterson, New Jersey, 07503, United States

  • Neurocrine Clinical Site

    Valley Stream, New York, 11580, United States

  • Neurocrine Clinical Site

    Chapel Hill, North Carolina, 27514, United States

  • Neurocrine Clinical Site

    Durham, North Carolina, 27710, United States

  • Neurocrine Clinical Site

    Portland, Oregon, 97227, United States

  • Neurocrine Clinical Site

    Nashville, Tennessee, 37232, United States

  • Neurocrine Clinical Site

    Dallas, Texas, 75231, United States

  • Neurocrine Clinical Site

    Houston, Texas, 77030, United States

  • Neurocrine Clinical Site

    Salt Lake City, Utah, 84108, United States

  • Neurocrine Clinical Site

    Seattle, Washington, 98105, United States

More trials for these conditions

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