A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
This important study, named ALKS 2680, is looking for adult volunteers who have Narcolepsy Type 2. The main goal is to find out if this new medicine can help people feel less sleepy during the day. Participants will be given either the new medicine or a 'dummy' pill (placebo) which looks exactly the same, but contains no active drug. This helps us fairly compare how well the medicine works. We will closely monitor how sleepy participants feel using a special scale, and also look at how long they can stay awake. The study also explores how the medicine affects their daily lives, as reported by the participants themselves. This is a crucial Phase 3 trial to learn more about the medicine's effectiveness and safety.
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¿De qué trata este estudio?
This research study is focused on a condition called Narcolepsy Type 2. This type of narcolepsy mainly causes excessive daytime sleepiness, which can make it hard to concentrate, stay awake, and carry out daily activities. The study is investigating a new medication, ALKS 2680, to see if it can help reduce this sleepiness and generally improve how people with Narcolepsy Type 2 feel.
To make sure the study gives reliable results, some participants will receive the new medicine while others will receive a 'placebo'. A placebo looks identical to the actual medicine but doesn't contain any active ingredients. This is a common and important practice in medical research – it helps scientists clearly see if any improvements are truly due to the new medicine and not just other factors. Neither you nor your study doctor will know if you are taking the active medicine or the placebo, which helps keep the trial fair and unbiased.
Over 12 weeks, the research team will regularly check how your sleepiness changes using a standard questionnaire called the Epworth Sleepiness Scale. They will also measure how long you can stay awake during specific tests and ask you about your own experiences and feelings. By collecting all this information, the study aims to confirm if ALKS 2680 is an effective and safe treatment option for adults living with Narcolepsy Type 2.
Puntos clave
- The study is testing a new medicine (ALKS 2680) for Narcolepsy Type 2.
- It aims to reduce daytime sleepiness and improve daily life.
- Participants will receive either the new medicine or a placebo (dummy pill).
- It's a 12-week study with regular check-ups and assessments.
- Only adults (18+) with Narcolepsy Type 2 can join.
- Your participation helps advance understanding and treatments for Narcolepsy Type 2.
¿Quién puede ser elegible?
This study is looking for adults aged 18 years and older who have been diagnosed with Narcolepsy Type 2. Both men and women are welcome to participate. Usually, specific medical conditions or medications might affect whether you can join, but the detailed criteria would be discussed with you by the study team.
It's important to know that before you can join, a doctor on the study team will carefully check your health and medical history. This is to make sure the study is safe for you and that the results collected will be useful for understanding how the new medicine works for people with Narcolepsy Type 2.
¿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 18 años o más?
- Have you been diagnosed with Narcolepsy Type 2?
- Are you comfortable with the possibility of receiving a 'dummy' pill (placebo)?
- Are you able to attend regular study appointments over 12 weeks?
- Are you willing to discuss your full medical history with the study team?
¿En qué consiste la participación?
If you decide to take part, you'll be assigned to either receive the new medicine (ALKS 2680) or a placebo (a dummy pill). You won't know which one you're getting, and neither will your study doctor. You'll take the assigned medication regularly over a 12-week period. During this time, you'll have several visits to the clinic for assessments. These visits will involve answering questions about your sleepiness and how you're feeling, and undergoing specific tests to measure your wakefulness. There will also be follow-up checks after the 12 weeks to see how you're doing. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained before you agree to join.
Riesgos y beneficios potenciales
Ubicaciones (4)
- —No verificadoPaíses Bajos
- —No verificadoBélgica
- —No verificadoItalia
- —No verificadoFrancia
Preguntas comunes
What is Narcolepsy Type 2?
Narcolepsy Type 2 is a long-term sleep disorder where you feel very sleepy during the day, even if you had enough sleep at night. It's different from Type 1 because it doesn't usually cause sudden muscle weakness (cataplexy).
What does 'placebo-controlled' mean?
It means some participants will get the actual medicine and others will get a 'dummy' pill that looks the same but has no medicine in it. This helps researchers compare the effects fairly.
Will I know if I'm taking the real medicine or the placebo?
No, during the study, neither you nor your doctor will know whether you're receiving the active medicine or the placebo. This is to make sure the study results are as accurate as possible.
¿Cuánto tiempo estaré en el estudio?
The main treatment period is 12 weeks, during which you'll take the study medicine or placebo. There will also be initial checks and follow-up visits, so the total time will be longer and will be clearly explained to you.
¿Qué es la Escala de Somnolencia de Epworth?
It's a simple questionnaire that asks how likely you are to doze off or fall asleep in different everyday situations. It helps doctors understand how sleepy you feel during the day.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
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