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 2
This research study is investigating a new medication, ALKS 2680, for individuals diagnosed with Narcolepsy Type 2. The main goal is to understand if this new drug is safe to use and how well it helps reduce the excessive daytime sleepiness commonly experienced with this condition. Participants will be divided into groups, some receiving different doses of ALKS 2680 and others a placebo (a dummy pill with no active medicine). This comparison helps researchers determine the drug's effectiveness. We'll be closely monitoring how participants' sleepiness changes over eight weeks and looking at other health measures to check for any side effects.
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¿De qué trata este estudio?
This clinical trial is designed to see if a new medicine, called ALKS 2680, can help people who have Narcolepsy Type 2. Narcolepsy Type 2 is a condition that makes people feel very sleepy during the day, even after a full night's sleep. This can make everyday activities challenging and can often be difficult to manage.
The main aim of this study is to look at how safe ALKS 2680 is and how well it works to reduce daytime sleepiness. We will be comparing different amounts (doses) of ALKS 2680 to see which might be most effective. Some volunteers will receive the new medicine, while others will be given a placebo, which looks just like the study medicine but contains no active ingredients. This is a common way to test new drugs reliably.
Researchers will be carefully tracking changes in how sleepy participants feel and how easily they can stay awake during the day over an 8-week period. They will also be checking various health markers, like blood tests, heart readings, and looking for any side effects, to make sure the treatment is as safe as possible.
Puntos clave
- This study evaluates a new drug, ALKS 2680, for Narcolepsy Type 2.
- It aims to check the safety and how well it reduces daytime sleepiness.
- Participants will receive either different doses of ALKS 2680 or a placebo.
- The main treatment period is 8 weeks, with close monitoring for effects and side effects.
- Results could help improve future treatments for Narcolepsy Type 2.
¿Quién puede ser elegible?
To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other criteria.
This study is open to both men and women. The researchers want to include a wide range of people to make sure the results are relevant to everyone who might one day benefit from this new treatment.
Beyond age and gender, there will be other specific health requirements that your doctor will check. These are in place to make sure the study medication is safe for you and that the study results are clear and accurate.
¿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.
- ¿Tienes al menos 18 años?
- Have you been diagnosed with Narcolepsy Type 2?
- Are you comfortable visiting a clinic regularly for assessments?
- Do you understand that you might receive a placebo?
- ¿Eres capaz de seguir las instrucciones de estudio cuidadosamente?
¿En qué consiste la participación?
If you decide to take part, you would first go through a screening process to check if you're suitable for the study. This would involve medical checks and answering questions about your health. If you qualify, you'd be given either ALKS 2680 or a placebo, which you'd take as instructed by the study team.
During the study, you would have regular visits to the clinic over a period of several weeks. At these visits, the research team would carry out different assessments. These might include tests to measure your alertness, questionnaires about how sleepy you feel, blood tests, checks of your vital signs (like blood pressure and heart rate), and possibly ECGs (heart rhythm tests). The team would be there to support you and answer any questions.
After the main treatment period, there will be an 'open-label' period, where all participants will have the option to receive ALKS 2680, and the study team will continue to monitor your health. The total duration of your involvement, including all visits and follow-ups, would be explained in detail before you agree to join.
Riesgos y beneficios potenciales
Ubicaciones (6)
- —No verificadoEspaña
- —No verificadoChequia
- —No verificadoFrancia
- —No verificadoItalia
- —No verificadoPaíses Bajos
- —No verificadoBélgica
Preguntas comunes
What is Narcolepsy Type 2?
It's a long-term condition that causes overwhelming daytime sleepiness and can make it hard to stay awake and alert during the day.
What is ALKS 2680?
It's a new medication being tested to see if it can help reduce the sleepiness caused by Narcolepsy Type 2.
¿Qué es un placebo?
A placebo is a dummy pill that looks like the study medicine but has no active drug in it. It helps compare the new medicine's effects accurately.
¿Cuánto tiempo durará el estudio?
The main part of the study involves taking the medication for 8 weeks, with regular visits. There might also be a longer 'open-label' period where everyone can receive the active drug.
Will I know if I'm getting the real drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting the active drug and who is getting the placebo until after the study is over.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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