RecruitingPHASE2, PHASE3INTERVENTIONAL

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

This study is looking at a new medicine called TAK-861 for people who have narcolepsy type 1. Its main purpose is to see how safe this medicine is and how well the body tolerates it over time. We also want to find out if TAK-861 can help improve common narcolepsy symptoms, such as feeling very sleepy during the day and having episodes of sudden muscle weakness (cataplexy). This trial is for people who have already taken TAK-861 in an earlier study. All participants in this study will receive TAK-861. It will last about 5 years and involves visits to a clinic for check-ups. The study aims to gather more information about TAK-861 before it can potentially become a new treatment option for narcolepsy type 1.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Takeda

Enrolment target

500

Start

05 Apr 2023

Estimated completion

28 Feb 2028

Narcolepsy Type 1

What is this study about?

This study is investigating a new medicine called TAK-861. It's specifically for people who have narcolepsy type 1, a long-term condition that affects the brain's ability to regulate sleep and wakefulness, often causing extreme daytime sleepiness and sudden temporary muscle weakness (cataplexy). The main goals of this research are to check how safe TAK-861 is and how well people tolerate it, especially since participants have already taken this medicine in previous studies. We also want to see if it helps reduce narcolepsy symptoms, like feeling overly sleepy during the day and having cataplexy episodes.

This study is a continuation of earlier research into TAK-861. Initially, part of the earlier study included people with a different type of narcolepsy (type 2), but those participants are no longer part of this particular extension study. This means that only those who have narcolepsy type 1 and have previously taken TAK-861 in a qualifying earlier study are eligible to join this current research. This helps us focus on gathering detailed, long-term information specifically about TAK-861 for narcolepsy type 1.

Up to 500 people will take part in this study, and everyone will receive TAK-861. If you were in an earlier study and received a dummy treatment (placebo), you would now be randomly assigned to one of the TAK-861 doses. This research is taking place in many different hospitals and clinics around the world, including the UK, and is expected to last for about 5 years. It's an important step in understanding TAK-861 better and hopefully bringing new treatment options to people with narcolepsy type 1.

Key takeaways

This study is testing TAK-861 for narcolepsy type 1.
It aims to check the medicine's safety and effectiveness for symptoms like daytime sleepiness and cataplexy.
Only people who have already taken TAK-861 in a previous study can join.
All participants will receive TAK-861 in this study.
The study will last around 5 years with regular clinic visits.
It's a global study aiming to find new treatment options.

Who may be eligible?

To be able to join this study, you must have previously completed another study where you received TAK-861 for narcolepsy type 1. Your study doctor also needs to agree that it's safe and appropriate for you to continue.

There are several reasons why someone might not be able to join. For example, if you had serious side effects in the previous study that haven't gone away, or if you had to stop that study because of side effects, you wouldn't be able to participate. Also, if there's any concern about your mental health (like a high risk of suicide or a recent severe depressive episode) or certain serious medical conditions, such as severe liver or heart problems, a recent history of cancer, or a history of seizures, you might not be eligible. They also check for other conditions that cause daytime sleepiness, as well as problems with your gut that might affect how your body absorbs medicines.

This study is open to both men and women, aged between 16 and 70 years old. These rules are in place to help make sure the study is as safe as possible for everyone involved and that the results are clear.

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.

I have been diagnosed with narcolepsy type 1.
I have already completed a previous study where I took TAK-861.
I am between 16 and 70 years old.
I haven't had severe side effects from TAK-861 in the previous study that are still ongoing.
I do not have certain serious health conditions like severe heart disease, liver problems, or a recent history of cancer or seizures.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given TAK-861 as the study medicine. Everyone in this study will receive the active medicine. If you were part of a previous study and received a dummy medicine (placebo), you would now be randomly assigned to one of the TAK-861 doses.

The study is expected to last for about 5 years. During this time, you'll need to visit the clinic a number of times for check-ups and assessments. Some of these visits might be able to happen at your home. After you take your last dose of the study medicine, there will be one final follow-up check-up about 4 weeks later to see how you are doing.

Potential risks and benefits

Participating in this study might offer you some potential benefits, as TAK-861 could help improve your narcolepsy symptoms, like excessive daytime sleepiness and cataplexy. However, as with any medicine, there are potential risks, and you might experience side effects. The study aims to carefully monitor these to gather more information about the medicine's safety. You will be fully informed about all known risks before you decide to participate. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (52)

Sleep Disorders Center of Alabama
Verified postcode
Birmingham, United States· Recruiting
Stanford Center for Sleep Sciences and Medicine
Verified postcode
Redwood City, United States· Recruiting
SDS Clinical Trials, Inc.
Verified postcode
Santa Ana, United States· Recruiting
Delta Waves LLC - Hunt - PPDS
Verified postcode
Colorado Springs, United States· Recruiting
Florida Pediatric Research Institute
Verified postcode
Orlando, United States· Recruiting
Neurotrials Research
Verified postcode
Atlanta, United States· Recruiting
Georgia Neuro Center
Verified postcode
Gainesville, United States· Recruiting
Neurocare Inc
Verified postcode
Newton, United States· Recruiting
Henry Ford Medical Center - Columbus
Verified postcode
Novi, United States· Recruiting
Research Carolina Elite
Verified postcode
Denver, United States· Recruiting
ARSM Research, LLC
Verified postcode
Huntersville, United States· Recruiting
CTI Research Center
Verified postcode
Cincinnati, United States· Recruiting

Common questions

What is narcolepsy type 1?

Narcolepsy type 1 is a condition where your brain has trouble controlling sleep and wakefulness, leading to extreme tiredness during the day and sometimes sudden muscle weakness called cataplexy.

Who can join this study?

Only people with narcolepsy type 1 who have already taken TAK-861 in a previous study and meet other specific health requirements can join.

Will I definitely get the actual medicine?

Yes, everyone in this particular study will receive TAK-861. There is no placebo group in this specific extension study.

How long will the study last and what will it involve?

The study will last about 5 years and involves regular visits to the clinic for check-ups, with a final follow-up visit about a month after your last dose.

What is the purpose of this study?

The main purpose is to learn more about the safety and long-term effects of TAK-861 in people with narcolepsy type 1, and if it helps their symptoms.

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.