Open-label single dose trial to evaluate pharmacokinetics, safety, and acceptability/palatability of oveporexton in children from 6 years to less than 18 years of age with narcolepsy type 1 (NT1)
This research is testing a new medicine called oveporexton for children and teenagers aged 6 to under 18 years old who have narcolepsy type 1. This condition causes extreme daytime sleepiness and can include sudden muscle weakness triggered by strong emotions (cataplexy). The study aims to understand how the body processes this new medicine after a single dose. Researchers will look at things like how much medicine gets into the blood, how quickly it gets there, and how long it stays in the system. They will also carefully watch for any side effects to make sure it's safe. Finally, the study will ask participants about their experience, checking if the medicine is acceptable and even if it tastes good, which is important for children. This is an early stage study to gather important basic information about the drug.
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¿De qué trata este estudio?
This study is about a new medicine called oveporexton, which is being developed for children and teenagers who have narcolepsy type 1. Narcolepsy type 1 is a long-term condition that makes people feel very sleepy during the day, even if they've had enough sleep at night. It can also cause sudden muscle weakness, called cataplexy, which might happen when someone laughs or feels strong emotions.
The main goal of this study is to find out how a single dose of this new medicine behaves inside the body. This means researchers will measure how much of the medicine gets into the bloodstream, how quickly it reaches its highest level, and how long it stays in the body. This information is really important for understanding how the medicine works and for planning future studies.
Another key part of this study is checking the safety of the medicine. Researchers will carefully watch for any side effects or unexpected reactions. They also want to know if children find the medicine easy to take and if they like the taste, as this can make a big difference for medicines that children need to take regularly. This is an early phase study, meaning it’s one of the first times this medicine is being tested in children, so it focuses on basic information about how it works and whether it’s safe enough to study further.
Puntos clave
- This study is for children (6-17 years old) with narcolepsy type 1.
- It tests a new medicine called oveporexton (TAK-861).
- The main goals are to check how the body handles the medicine, its safety, and if it's easy to take.
- This is an early-stage study to gather basic information.
- Participation involves taking a single dose and having health checks.
¿Quién puede ser elegible?
This study is looking for children and teenagers with narcolepsy type 1 who are between 6 and under 18 years old. Both boys and girls can take part in this research.
Unfortunately, the brief information available doesn't provide many details about other health conditions or medicines that might prevent someone from joining. However, usually, studies like this have strict rules about who can and cannot take part to ensure safety and that the results are clear.
If you're interested, your doctor will be able to check if you or your child meets all the specific requirements for this study. They will review your full medical history and current health to make sure it's safe and appropriate for you to participate.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- I have been diagnosed with narcolepsy type 1.
- I am between 6 and under 18 years old.
- I am generally healthy apart from my narcolepsy (this will be confirmed by a doctor).
- I am willing and able to follow all study instructions.
¿En qué consiste la participación?
If you or your child joins this study, you'll receive a single dose of the new medicine, TAK-861 (also called oveporexton). The study will closely monitor how your body handles this medicine. This typically involves having blood samples taken at different times to measure the medicine's levels. You might also have other health checks, like heart rate and blood pressure measurements, to ensure your safety.
After you take the medicine, researchers will carefully watch for any side effects. You'll also be asked to share your honest opinion about how easy the medicine was to take and if you liked the taste. The exact number of visits, how long each visit lasts, and the total duration of your participation will be explained in detail by the study team before you decide to join.
Riesgos y beneficios potenciales
Ubicaciones (1)
- —No verificadoItalia
Preguntas comunes
What is narcolepsy type 1?
Narcolepsy type 1 is a condition that causes extreme daytime sleepiness and can also lead to sudden muscle weakness called cataplexy, often triggered by strong emotions.
What is the new medicine being tested?
The new medicine is called oveporexton, also known as TAK-861. This study is an early step in understanding how it works.
¿Quién puede participar en este estudio?
Children and teenagers with narcolepsy type 1, aged from 6 to under 18 years old, can be considered for this study.
¿Qué tendré que hacer si me uno?
You'll take a single dose of the medicine and have your blood tested to see how your body processes it. They will also check your safety and ask about your experience taking the medicine.
Are there any side effects?
As with any medicine, there's a chance of side effects. The study team will explain all known risks to you before you decide to join.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.