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New nasal spray aims to curb relentless hunger in rare genetic disorder

NCT ID NCT06420297

Disease control Sponsor: ACADIA Pharmaceuticals 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 2 times

Summary

This study tests the long-term safety of a nasal spray called carbetocin for people with Prader-Willi syndrome who experience severe, constant hunger (hyperphagia). About 160 participants who completed a previous study will receive the spray three times daily. The goal is to see if the treatment is safe and tolerable over an extended period.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

168 people

The number who actually took part.

Started

Mar 2024

Finished

Dec 2025

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.

Ages

5 to 30 years

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: * Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302 * Met all entry criteria for the antecedent study * May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator. * Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits. Exclusion Criteria: * History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary. * Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder * History of suicide attempt or inpatient psychiatric hospitalization * Has a clinically significant abnormality in vital signs at Baseline * Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study) * Has developed a clinically significant ECG finding during the antecedent study * Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

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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.

Hyperphagia in Prader-Willi syndrome

Contacts and locations

Locations

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1, Canada

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Barts Health NHS Trust - The Royal London Hospital

    London, E1 1B6, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital des Enfants

    Toulouse, Cedex 9 Occitanie, 31059, France

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Christus Children's

    San Antonio, Texas, 78207, United States

  • Cook Children's Health Care System

    Fort Worth, Texas, 79104, United States

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, 29009, Spain

  • KJF Klinik Josefinum gGmbH

    Augsburg, 86154, Germany

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Parc Taulí Hospital Universitari

    Barcelona, 08208, Spain

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85006, United States

  • Rady Children's Hospital San Diego

    San Diego, California, 92123, United States

  • Royal Hospital for Children Glasgow Clinical

    Glasgow, G51 4TF, United Kingdom

  • SSM Health/Saint Louis University

    St Louis, Missouri, 63104, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • UPMC-Children's Hospital Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • University of California Irvine

    Orange, California, 92697, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Vanderbilt Clinical Research Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.