Not recruitingRare disease

Study on the Safety of Carbetocin Nasal Spray for Treating Uncontrollable Hunger in Patients with Prader-Willi Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Prader-Willi Syndrome (PWS), which is a genetic disorder that can cause a constant feeling of hunger, known as hyperphagia. The trial is testing a treatment using a medication called Carbetocin Nasal Spray, which is an oxytocin-like chemical designed to help manage this uncontrollable hunger.

The purpose of the study is to learn about the safety of using Carbetocin Nasal Spray over a long period. Participants in the study will use the nasal spray, which is administered through the nose, to see if it helps reduce the symptoms of hyperphagia. The study will monitor participants for any side effects or changes in their condition while using the spray.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. These check-ups will include questionnaires and evaluations to track changes in their hunger levels and overall well-being. The study aims to provide valuable information on how safe and effective Carbetocin Nasal Spray is for people with Prader-Willi Syndrome.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The study begins with the administration of carbetocin nasal spray. This medication is used to address uncontrollable hunger associated with Prader-Willi Syndrome.
The nasal spray is administered through the nose, as it is designed for intranasal use.
Step 2
Medication schedule
The dosage and frequency of the carbetocin nasal spray will be determined by the study protocol and the healthcare provider overseeing the trial.
The treatment is intended for long-term use, with regular monitoring to ensure safety and effectiveness.
Step 3
Monitoring and assessments
Throughout the trial, regular assessments will be conducted to monitor the safety and effectiveness of the treatment.
These assessments include checking for any adverse events, which are unexpected medical issues that may arise during the study.
Step 4
Questionnaires and evaluations
Participants will complete various questionnaires to evaluate changes in symptoms and overall well-being.
These include the Hyperphagia Questionnaire for Clinical Trials and the Clinical Global Impression scales, which help measure the severity of symptoms and any improvements over time.
Step 5
Caregiver involvement
A caregiver will be involved in the study to assist with the administration of the nasal spray and to provide information during assessments.
The caregiver must be able to follow study procedures and communicate effectively with the study team.
Step 6
Completion of the study
The study is expected to continue until July 2028, with regular follow-ups and assessments throughout this period.
Upon completion, the data collected will be analyzed to determine the long-term safety and effectiveness of the carbetocin nasal spray for treating hyperphagia in Prader-Willi Syndrome.

Who can join the trial?

15 criteria

The patient or their legal representative must give informed consent before any study procedures begin. This means they agree to participate after understanding the study details.
If the patient is a minor, their legal representative must provide written consent. The patient should also agree if they are able to understand.
If the patient is an adult, they must provide written consent unless they have a guardian. If they have a guardian, the guardian must provide consent, and the patient should agree if they can understand.
The patient's caregiver must also agree to participate in the study assessments.
The patient must have completed a previous related study up to the 12-week mark.
The patient must have met all the requirements for the previous study.
The study doctor must believe that the patient may benefit from long-term treatment with the study medication.
The patient must live with a caregiver who understands the study procedures and agrees to participate in all study visits.
The caregiver must be a family member or someone who has cared for the patient for at least 6 months and plans to continue caring for them during the study.
The caregiver must be able to communicate in the language of the study and use electronic devices for study visits and questionnaires.
The caregiver must be able to receive and store the study medication as instructed.
The caregiver must be able to attach the nasal spray device to the medication vial.
If the patient is female, she must not be pregnant or breastfeeding. If she can have children, she must avoid sexual activity or use a highly effective birth control method during the study and for at least 30 days after.
If the patient is male and sexually active, he must use a condom during the study and for 90 days after the last dose of the study medication. His female partner must also use a highly effective birth control method during this time.
Male patients must agree not to donate sperm during the study and for 90 days after the last dose of the study medication.

Who cannot join the trial?

4 criteria

Individuals who do not have **Prader-Willi Syndrome (PWS)**, a genetic condition that affects many parts of the body, cannot participate.
Participants must be within the specified age range for the study.
Both males and females are eligible, but those who do not meet the gender criteria cannot participate.
Individuals who are not part of the vulnerable population selected for the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital General Universitario Gregorio Maranon
Madrid, Spain
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Oncopole Claudius Regaud
Toulouse, France
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Parc Tauli Hospital Universitari
Sabadell, Spain

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Investigated drugs

Carbetocin Nasal Spray is being studied for its potential to help manage hyperphagia, which is an excessive hunger or increased appetite, in individuals with Prader-Willi Syndrome (PWS). This medication is administered through the nose and is being evaluated for its safety and how well it is tolerated when used over a long period.

Carbetocin

What is already known about the treatment

Carbetocin Nasal Spray – This medication is administered as a nasal spray and is currently being studied in clinical trials for its safety and tolerability in treating hyperphagia, a condition characterized by excessive eating, associated with Prader-Willi Syndrome (PWS). Carbetocin is a synthetic hormone that mimics oxytocin, which plays a role in social bonding and appetite regulation. It is classified as an oxytocin analog and works by binding to oxytocin receptors in the brain, potentially reducing the urge to eat excessively. The medication is still under investigation, and its effectiveness and safety are being evaluated in ongoing studies.

Investigated diseases

Prader-Willi Syndrome – Prader-Willi Syndrome is a genetic disorder that affects many parts of the body. One of the main features of this condition is hyperphagia, which is an intense and chronic feeling of hunger that can lead to excessive eating and obesity. Individuals with this syndrome may also experience developmental delays, intellectual disabilities, and behavioral problems. The condition is caused by the loss of function of specific genes on chromosome 15. It is considered a rare disease and can vary in severity among those affected.