In short
Currently, there are 2 ongoing clinical trials investigating treatments for hyperphagia, particularly in patients with Prader-Willi Syndrome. Both studies are evaluating the safety and effectiveness of Carbetocin Nasal Spray, a medication designed to help manage uncontrollable hunger. These trials are being conducted across multiple European countries.
Clinical trial locations
- Belgium
- France
- Germany
- Italy
- Spain
Study on the Safety of Carbetocin Nasal Spray for Treating Uncontrollable Hunger in Patients with Prader-Willi Syndrome
This trial focuses on studying the long-term safety of Carbetocin Nasal Spray in patients with Prader-Willi Syndrome who experience constant, uncontrollable hunger. Carbetocin is a synthetic hormone similar to oxytocin that may help regulate appetite. The medication is administered as a nasal spray, making it easy to use at home.
Who can participate:
- Patients must have completed a previous related study up to the 12-week mark
- Participants must be within the specified age range and have confirmed Prader-Willi Syndrome
- A caregiver must live with the patient and be able to assist with medication administration and attend all study visits
- The caregiver must be a family member or someone who has cared for the patient for at least 6 months
- Female participants who can become pregnant must use highly effective birth control during the study and for at least 30 days after
- Male participants who are sexually active must use condoms during the study and for 90 days after the last dose
Who cannot participate:
- Individuals who do not have Prader-Willi Syndrome
- Those who fall outside the specified age range
- Participants who do not meet the gender criteria or other requirements
Main focus of the trial: This study is designed to monitor the safety of long-term use of Carbetocin Nasal Spray. Throughout the trial, which is expected to continue until July 2028, participants will have regular check-ups to assess any side effects or changes in their condition. Researchers will use questionnaires and clinical evaluations to track changes in hunger levels and overall well-being. The involvement of caregivers is crucial, as they will help administer the medication and provide information during assessments.
Investigational drug: Carbetocin Nasal Spray is an oxytocin analog that works by binding to oxytocin receptors in the brain, potentially reducing the excessive urge to eat.
Study on Carbetocin Nasal Spray for Reducing Uncontrollable Hunger in Patients with Prader-Willi Syndrome
This trial is testing whether Carbetocin Nasal Spray can effectively reduce excessive hunger in people with Prader-Willi Syndrome. The study compares the effects of the active medication to a placebo (a substance with no active medication) over a 12-week period.
Who can participate:
- Patients between 5 and 30 years old with confirmed Prader-Willi Syndrome
- Must have increased appetite, decreased feeling of fullness, and food-seeking behavior
- Must have specific scores on questionnaires measuring appetite-related behavior
- Any long-term medications must have been taken at a stable dose for at least 3 months before the study
- Must live with a caregiver who can follow study procedures and participate in all visits
- The caregiver must be a family member or someone who has cared for the patient for at least 6 months and spends time with them regularly
- Female participants of childbearing potential must use highly effective birth control during the study and for 30 days after
- Male participants who are sexually active must use condoms, and their female partners must also use highly effective birth control during the study and for 90 days after
Who cannot participate:
- Individuals without Prader-Willi Syndrome or who are not experiencing excessive hunger
- Those outside the specified age range
- People unable to follow study procedures or instructions
- Those with other medical conditions that might interfere with the study
- People taking medications that could affect study results
- Pregnant or breastfeeding women
- Individuals who have participated in another clinical trial recently
Main focus of the trial: This is a Phase 3 study that will randomly assign participants to receive either Carbetocin Nasal Spray or a placebo. The nasal spray contains 11.4 mg/ml of carbetocin and is administered using a special nasal spray device. The primary goal is to determine if the medication can significantly reduce symptoms of excessive hunger compared to placebo. Participants will undergo regular assessments at various intervals, with a primary focus on changes from the beginning of the study to Week 12. The study is expected to conclude by April 2025.
Investigational drug: Carbetocin Nasal Spray is an oxytocin analog that mimics the action of oxytocin, a hormone that plays a role in regulating appetite and social behaviors, potentially reducing the urge to overeat in individuals with Prader-Willi Syndrome.
Summary
Both ongoing clinical trials are investigating the same medication, Carbetocin Nasal Spray, for managing uncontrollable hunger in patients with Prader-Willi Syndrome. The first trial focuses on long-term safety monitoring, while the second trial is evaluating the medication's effectiveness compared to placebo over a 12-week period. Together, these studies aim to provide comprehensive data on both the safety and effectiveness of this potential new treatment.
The trials are being conducted across five European countries: Germany, Spain, France, Belgium, and Italy. Notably, both France and Germany are participating in both trials, suggesting these countries may have significant research centers specializing in Prader-Willi Syndrome. The concentration of trials in Europe reflects a coordinated effort to address this challenging aspect of the genetic disorder.
Both studies emphasize the important role of caregivers, who must be actively involved throughout the trials. This reflects the reality that many patients with Prader-Willi Syndrome require ongoing support, particularly with medication management and behavioral monitoring. The requirement for stable medication doses and the careful monitoring of participants demonstrate the thorough approach being taken to ensure patient safety while testing this new treatment option.
