A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
This research study is looking at a new medicine called TAK-861 for adults who have a condition known as narcolepsy with cataplexy (sometimes called Type 1 narcolepsy). Narcolepsy causes extreme daytime sleepiness, and cataplexy involves sudden muscle weakness triggered by strong emotions. The main goal is to find out if TAK-861 can help people feel less sleepy and have fewer cataplexy attacks over 12 weeks. Researchers will also check to see how safe the medicine is and if it causes any unwanted side effects. To do this, some participants will receive the new medicine, and others will get a 'dummy' medicine (placebo) that looks the same but contains no active drug. This helps scientists accurately tell if the medicine is truly working.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication, TAK-861, for individuals living with narcolepsy type 1. Narcolepsy type 1 is a long-term condition that mainly affects how well you can stay awake and alert during the day. People with this condition often experience overwhelming daytime sleepiness, making it hard to concentrate and stay active. A key feature of type 1 narcolepsy is cataplexy, where strong emotions like laughter or anger can suddenly cause you to lose muscle control, leading to weakness or even collapsing.
The main purpose of this study is to see if TAK-861 can improve these symptoms, particularly the excessive daytime sleepiness and the frequency of cataplexy attacks. Researchers will also be carefully monitoring for any side effects to understand how safe the new medicine is for people to use. It's a 'Phase III' study, which means it's one of the final stages of testing before a new medicine might be considered for wider use by the general public.
To make sure the results are as fair and accurate as possible, the study compares TAK-861 with a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. Neither the participants nor their doctors will know who is getting the real medicine and who is getting the placebo until the study is over. This is a common and important step in medical research to truly understand if a new treatment is effective.
Key takeaways
- This study is testing a new medicine (TAK-861) for narcolepsy with cataplexy.
- It aims to see if TAK-861 reduces sleepiness and cataplexy attacks.
- Some participants will receive TAK-861, others a placebo (dummy medicine).
- The study will last around 12 weeks for treatment, plus follow-up.
- Participation helps advance understanding and potential new treatments.
Who may be eligible?
This study is open to adults who are at least 18 years old. Both men and women are welcome to take part.
To be considered for the study, you must have a clear diagnosis of narcolepsy with cataplexy, also known as Narcolepsy Type 1. This means you experience sudden muscle weakness or loss of control triggered by strong emotions.
There might be other specific medical requirements or factors that could affect whether you can join, such as other health conditions you might have or medicines you are currently taking. The study team will review all of this information with you to make sure it's safe and appropriate for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years of age or older?
- Have you been diagnosed with narcolepsy with cataplexy (Type 1)?
- Are you able to attend regular clinic visits?
- Are you willing to take a study medicine and keep a diary of your symptoms?
What does participation involve?
If you decide to take part in this study, you will be given study medicine (either TAK-861 or a placebo) to take regularly for 12 weeks. You will have several scheduled visits to the study clinic during this time. These visits will involve various tests and assessments, such as filling out questionnaires about your sleepiness and overall well-being, and having some simple health checks. Researchers will also use special sleep tests to understand how the medicine is affecting your sleep patterns.
Throughout the study, you'll be asked to keep track of your symptoms and any changes you notice. After the 12-week treatment period, there will be a follow-up visit to monitor your health and ensure everything is stable. The total duration from your first visit to your final follow-up will be several months, and the study team will explain the full schedule to you.
Potential risks and benefits
Locations (6)
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is narcolepsy with cataplexy?
It's a long-term brain condition causing severe daytime sleepiness and sudden muscle weakness (cataplexy) triggered by strong emotions.
What is TAK-861?
TAK-861 is a new investigational medicine being tested to see if it can help reduce symptoms of narcolepsy with cataplexy.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers fairly compare results.
Will I know if I'm getting the real medicine?
No, neither you nor your doctor will know if you're taking TAK-861 or the placebo until after the study is complete. This is called 'double-blind'.
How long does the study last?
You will take the study medicine for 12 weeks, with follow-up visits after this. The total time you're involved will be several months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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