A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
This research study is looking into a new medication called ALKS 2680 for people who have Narcolepsy Type 1. This condition causes extreme daytime sleepiness and sometimes sudden muscle weakness (cataplexy). The study is in an early stage (Phase 2), meaning it's still finding the best dose. Researchers want to understand if ALKS 2680 is safe and how effective different amounts of the medicine are at reducing symptoms like feeling very sleepy during the day. Participants will receive either the active medicine or a dummy pill, with doctors and patients not knowing who gets what until later, to ensure fair results. Taking part could help us learn more about managing Narcolepsy Type 1.
Em resumo
Sobre o que é este estudo?
This study is a research project designed to explore a new potential medicine for Narcolepsy Type 1. Narcolepsy Type 1 is a long-term condition that mainly causes people to feel extremely sleepy during the day, even after a full night's sleep. It can also cause sudden, temporary muscle weakness called cataplexy, often triggered by strong emotions like laughing or anger. The new medicine being tested, ALKS 2680, is hoped to help manage these symptoms.
The main goal of this particular study (known as a 'Phase 2' study) is to find out if ALKS 2680 is safe for people with Narcolepsy Type 1 and to see which doses of the medicine might work best. Researchers will be giving different groups of people different amounts of the medicine or a 'placebo' (a dummy pill that looks like the real medicine but contains no active ingredients) to compare the effects. This helps them understand the medicine's benefits and any side effects.
During the study, doctors and patients won't know who is getting the real medicine and who is getting the placebo for a period. This is called 'double-blind' and it helps make sure the results are as fair and unbiased as possible. After this initial period, all participants will know which dose they are receiving. The information gathered from this study will be crucial in deciding if ALKS 2680 should be studied further in larger groups of people, potentially leading to a new treatment option for Narcolepsy Type 1.
Pontos principais
- This study is for adults with Narcolepsy Type 1.
- It's testing a new medicine, ALKS 2680, for safety and how well different doses work.
- You might receive the active medicine or a placebo (dummy pill).
- Regular visits and health checks are part of participating.
- Your involvement could help develop new treatments for Narcolepsy Type 1.
- Você pode parar de participar a qualquer momento.
Quem pode ser elegível?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can take part. Both men and women are welcome to participate in this research.
You would need to have been diagnosed with Narcolepsy Type 1. The study is specifically looking for people with this condition to test how the new medicine works for them.
The research team will have a more detailed list of things they look for in participants, including your current health and any other medicines you might be taking. These checks are important to make sure the study is suitable and safe for you, and that the results can be properly understood.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Have you been diagnosed with Narcolepsy Type 1?
- Are you able to attend regular appointments at the study clinic?
- Are you comfortable filling out questionnaires and keeping a diary about your symptoms?
O que envolve a participação?
If you decide to take part, you would receive the study medicine (either ALKS 2680 or a placebo) and attend regular appointments with the study team. These appointments will involve tests to check how you're feeling, including your sleepiness levels using special questionnaires and sleep tests. They will also take blood samples, check your blood pressure and heart rate, and ask about any changes you notice in your health.
You would also be asked to keep a diary of any sudden muscle weakness episodes (cataplexy). The study will involve periods where you don't know if you're getting the active medicine or the placebo, and then periods where everyone knows and receives the active medicine. The total duration of your involvement will be explained by the study team, but it includes regular visits and follow-up assessments.
Riscos e benefícios potenciais
Localizações (6)
- —Não verificadoChéquia
- —Não verificadoItália
- —Não verificadoFrança
- —Não verificadoBélgica
- —Não verificadoEspanha
- —Não verificadoPaíses Baixos
Perguntas frequentes
What is Narcolepsy Type 1?
It's a long-term condition that causes extreme daytime sleepiness and sometimes sudden, temporary muscle weakness called cataplexy.
What is ALKS 2680?
It's a new medicine being tested to see if it can help reduce the symptoms of Narcolepsy Type 1.
What does 'Phase 2 study' mean?
It means the study is in an early stage, checking the medicine's safety and trying to find the best dose.
O que é um 'placebo'?
It's a dummy pill that looks like the real medicine but has no active ingredients. It's used for comparison.
Posso sair do estudo se mudar de ideia?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.