A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
This study is looking at a new medicine called TAK-861, for people who have narcolepsy with cataplexy, which is also known as Narcolepsy Type 1. The main goal is to find out how effective TAK-861 is at treating symptoms and if its helpful effects continue over time. We also want to check how safe it is and what side effects might happen. Participants will first take TAK-861 for a few months. After that, if they meet certain requirements, they will be randomly chosen to either continue with TAK-861 or switch to a dummy medicine (placebo) for up to four weeks. This helps us see if their narcolepsy symptoms come back when the active medicine is stopped. The study involves about 88 people aged 16 to 70 and is happening in different places around the world.
Em resumo
Sobre o que é este estudo?
This study is testing a new medicine called TAK-861 for people who have narcolepsy with cataplexy, also known as Narcolepsy Type 1. Narcolepsy is a long-term condition that causes a person to feel extremely sleepy during the day, even after getting enough sleep at night. Cataplexy is a sudden, temporary loss of muscle control, often triggered by strong emotions like laughter or surprise. The main purpose of this study is to see how well TAK-861 works to treat these symptoms and whether its positive effects last over time. We also want to understand if the medicine is safe to use and what side effects people might experience, both while taking it and if they stop taking it.
Here's how the study will generally work: All participants will first take TAK-861 for several months. This part of the study is 'open-label,' meaning everyone knows they are receiving the active medicine. After this initial period, some participants who meet specific conditions will be randomly chosen, like flipping a coin, to enter the next phase. In this phase, for up to four weeks, they will either continue taking TAK-861 at the same dose or switch to a 'placebo,' which is a dummy pill with no active medicine. This helps researchers understand if the medicine is truly making a difference compared to taking nothing.
The study involves about 88 people and is taking place in various locations globally. If someone's narcolepsy symptoms get worse during the 'dummy pill' phase, or if their sleepiness score goes above a certain level, they will stop that part of the treatment. They will then be invited to join a separate long-term study to continue receiving treatment. If they choose not to join the extension study, they will still be monitored for four weeks after their last dose to ensure their safety and well-being.
Pontos principais
- This study is for people with Narcolepsy Type 1 aged 16-70.
- It tests a new medicine called TAK-861 for effectiveness and safety.
- You'll take TAK-861 first, then might switch to a placebo for a short time.
- Your health and symptoms will be closely monitored throughout.
- You can leave the study at any time without affecting your medical care.
Quem pode ser elegível?
To join this study, you generally need to be between 16 and 70 years old. You must have a diagnosis of Narcolepsy Type 1 (which includes cataplexy) confirmed by specific medical guidelines. Also, a blood test or a spinal fluid test will be done to check for certain markers related to narcolepsy.
There are also some reasons why you might not be able to join. For example, if you have other medical conditions that cause extreme daytime sleepiness, aside from your narcolepsy, you likely won't be eligible. Also, certain serious health problems, such as a recent heart attack, significant liver disease, certain heart conditions, or a history of cancer within the last five years, would prevent you from taking part.
Other reasons for not being able to participate include having certain digestive conditions that might affect how your body absorbs medicines, a significant head injury, epilepsy or seizures (except for a single fever-related seizure in childhood), or a history of certain brain or blood vessel issues like strokes or aneurysms in the brain. The study also has a healthy weight range requirement (Body Mass Index between 18 and 40).
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.
- Are you between 16 and 70 years old?
- Do you have a diagnosis of Narcolepsy Type 1 (with cataplexy)?
- Have you had serious heart, liver, or kidney problems?
- Have you had cancer in the last 5 years?
- Do you have a history of epilepsy or certain brain conditions?
- Are you within a healthy weight range (BMI 18-40)?
O que envolve a participação?
If you decide to take part in this study, you will first receive the study medicine, TAK-861, for several months. During this time, you'll have regular visits where the study team will monitor your health, how well the medicine is working, and if you're experiencing any side effects. You'll likely undergo various assessments during these visits, such as filling out questionnaires about your sleepiness and overall well-being, and having physical exams.
After this initial period, if you meet certain criteria, you'll be randomly assigned to either continue taking TAK-861 or switch to a dummy pill (placebo) for up to four weeks. During this shorter period, your symptoms will be closely watched to see if they change. If your narcolepsy symptoms worsen significantly, you will stop this phase of the study and be offered the chance to join a long-term study where you would receive TAK-861 again. If you choose not to join the long-term study, you'll still have a follow-up period of four weeks after your last dose of study medicine to ensure your safety.
Riscos e benefícios potenciais
Localizações (18)
- Takeda Site 1Código postal verificadoRedwood City, Estados Unidos· Recrutamento
- Takeda Site 4Código postal verificadoBrandon, United States· Recrutamento
- Takeda Site 6Código postal verificadoMiami, Estados Unidos· Recrutamento
- Takeda Site 7Código postal verificadoSouthfield, United States· Recrutamento
- Takeda Site 16Código postal verificadoMiddletown, United States· Recrutamento
- Takeda Site 17Código postal verificadoDurham, Estados Unidos· Recrutamento
- Takeda Site 18Código postal verificadoWinston-Salem, Estados Unidos· Recrutamento
- Takeda Site 2Código postal verificadoCincinnati, Estados Unidos· Recrutamento
- Takeda Site 15Código postal verificadoCleveland, Estados Unidos· Recrutamento
- Takeda Site 3Código postal verificadoColumbia, Estados Unidos· Recrutamento
- Takeda Site 5Código postal verificadoAustin, Estados Unidos· Recrutamento
- Takeda Site 8Código postal verificadoMontpellier, France· Recrutamento
Perguntas frequentes
What is Narcolepsy Type 1?
Narcolepsy Type 1 is a long-term condition that makes people very sleepy during the day and can cause sudden, temporary muscle weakness, often triggered by strong emotions.
What is TAK-861?
TAK-861 is a new medicine being tested to see if it can help improve symptoms for people with Narcolepsy Type 1.
O que é um 'placebo'?
A placebo is a 'dummy' pill that looks like the study medicine but contains no active drug. It helps researchers compare the effects of the actual medicine.
Will I know if I'm getting TAK-861 or a placebo?
During the first part of the study, everyone receives TAK-861. In a later, shorter part, you might be randomly assigned to either TAK-861 or a placebo, and neither you nor the doctors will know which one you are taking until after that part finishes.
Quanto tempo estarei no estudo?
The study involves an initial period of taking TAK-861 for several months, followed by a shorter period of up to four weeks where you might switch to a placebo. There's also a follow-up period if you don't join an extension study.
Como saber mais
Contato Takeda
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.