A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
This ongoing study is testing a nasal spray called Carbetocin for adults aged 18 and older who have Prader-Willi Syndrome. The main goal is to understand if this spray can safely help reduce their strong, continuous hunger, known as hyperphagia, over a long period. Researchers will be carefully monitoring for any side effects and how often they occur. They will also look at how the spray might improve related behaviours and the overall quality of life for participants and their caregivers. This is a follow-up to earlier studies, aiming to confirm the long-term safety and effectiveness of Carbetocin in managing this challenging symptom.
Auf einen Blick
Worum geht es in dieser Studie?
This study is a long-term follow-up to previous research on a new nasal spray called Carbetocin. It's designed for adults aged 18 and over who have Prader-Willi Syndrome (PWS) and experience hyperphagia, which is a constant, overwhelming feeling of hunger that can be very difficult to manage. The main purpose of this particular study is to see how safe the Carbetocin nasal spray is when used over a longer period.
Researchers will be carefully tracking any side effects that people experience, whether minor or more serious, and understand if anyone needs to stop using the spray because of these effects. They will also check if the medical device itself (the nasal spray bottle) works correctly and doesn't cause any problems. This is an important step to make sure the treatment is safe for people to use routinely.
Beyond safety, the study will also look at whether the nasal spray helps to reduce the constant hunger and improve other related behaviours linked to PWS. They will use questionnaires and assessments to see if participants' eating habits improve, how their mood and anxiety levels change, and if the overall burden on their caregivers becomes lighter. This helps scientists understand the full impact of the treatment on daily life for those with PWS.
Wichtige Erkenntnisse
- This study is for adults with Prader-Willi Syndrome experiencing constant hunger.
- It tests a nasal spray called Carbetocin over a long period.
- The main focus is to check the long-term safety of the spray.
- It also assesses if the spray improves hunger and related behaviours.
- Participation involves using the spray and attending regular check-ups.
- You can leave the study at any time you wish.
Wer könnte berechtigt sein?
To be eligible for this study, you must be an adult, meaning you are 18 years old or older. There is no upper age limit, so older adults can also take part.
Both men and women are welcome to join the study.
The main requirement is that you have Prader-Willi Syndrome and experience the constant, overwhelming hunger known as hyperphagia, which this treatment aims to help with. Your doctors will need to confirm your diagnosis and current symptoms to ensure the study is right for you.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie 18 Jahre alt oder älter?
- Do you have a diagnosis of Prader-Willi Syndrome?
- Do you experience significant, constant hunger (hyperphagia)?
- Are you willing and able to use a nasal spray regularly?
- Can you attend regular clinic visits for assessments?
Was beinhaltet die Teilnahme?
If you decide to take part in this study, you would be using the Carbetocin nasal spray as directed by the study doctors. You would need to attend regular visits at a clinic. During these visits, the study team would perform various checks. These include asking you about any side effects you might have had, carrying out physical examinations, and having you or your caregiver fill out questionnaires about your eating habits, behaviour, and daily life.
The study will continue for a long period to fully understand the long-term effects of the spray. The exact number of visits and the full duration would be explained in detail by the study team, but it's designed to be an ongoing assessment of the treatment's safety and effectiveness over time. You will be closely monitored throughout.
Potenzielle Risiken und Vorteile
Standorte (3)
- —UnbestätigtDeutschland
- —UnbestätigtSpanien
- —UnbestätigtFrankreich
Häufige Fragen
What is hyperphagia?
Hyperphagia is a very strong, constant feeling of hunger that doesn't go away, often experienced by people with Prader-Willi Syndrome. It can make it very hard to control eating.
What is Carbetocin nasal spray?
Carbetocin nasal spray is a potential new medicine that is being tested to see if it can help reduce the strong hunger symptoms in people with Prader-Willi Syndrome, by delivering the medicine directly into the nose.
What kind of checks will happen during the study?
You'll have regular check-ups where the study team will ask about your health, any side effects, and your eating and behaviour patterns using questionnaires. They'll also do general health checks.
Wie lange muss ich an der Studie teilnehmen?
This is a long-term study, so your participation could last for an extended period. The exact duration would be discussed with you by the study team.
Kann ich aufhören teilzunehmen, wenn ich meine Meinung ändere?
Yes, absolutely. You can decide to leave the study at any time, for any reason, without having to explain why, and it won't affect your regular medical care.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
Interessiert daran, teilzunehmen?
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