A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
Narcolepsy type 1 is a long-term brain condition that causes severe daytime sleepiness and sudden loss of muscle control, known as cataplexy. This trial is studying an experimental medicine called TAK-360 to see if it is safe, well-tolerated, and effective at easing these symptoms. Researchers are conducting a Phase 2 trial comparing TAK-360 against a placebo (a dummy pill containing no active medication). Neither you nor the study team will know which treatment you receive. Over at least six weeks, doctors will monitor you closely for any unwanted side effects. They will also measure how well you can stay awake during the day and track changes in your muscle weakness episodes. Taking part is entirely voluntary, and adults aged 18 and over with narcolepsy with cataplexy may be able to join.
At a glance
What is this study about?
Narcolepsy type 1 is a sleep disorder that affects how the brain controls sleep and wake cycles. People with the condition often feel overwhelming daytime tiredness and can fall asleep unexpectedly. They also experience cataplexy, which is a sudden, temporary loss of muscle strength often triggered by strong emotions such as laughter, surprise, or anger. Living with these symptoms can make day-to-day activities like working, socialising, or driving very difficult.
While treatments currently exist to help manage narcolepsy, they do not work well for everyone and can sometimes cause unwanted side effects. This clinical trial is evaluating a new experimental tablet called TAK-360. Scientists want to discover whether TAK-360 is safe to use and whether it can effectively reduce extreme sleepiness and muscle weakness.
During the study, participants will be closely monitored by specialist doctors. Researchers will use standard sleep tests and questionnaires to see if daytime alertness improves and whether the weekly number of cataplexy attacks goes down. If the trial is successful, it could help lead to a new treatment option for people living with this challenging condition.
Key takeaways
- Tests an experimental drug called TAK-360 for narcolepsy type 1.
- Open to adults aged 18 and older with narcolepsy and cataplexy.
- Compares the study drug to a dummy pill (placebo) over at least six weeks.
- Aims to check safety, daytime wakefulness, and muscle weakness attacks.
- Joining is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with narcolepsy with cataplexy (also known as narcolepsy type 1). Both men and women can join.
To take part, you should currently be experiencing regular symptoms of narcolepsy, such as difficulty staying awake during the day and sudden episodes of muscle weakness. The study team will need to confirm your diagnosis and review your overall health.
You might not be eligible if you have other serious medical conditions, specific sleep disorders unrelated to narcolepsy, or if you take certain medicines that cannot be safely adjusted or paused during the trial. The study doctor will check all of these factors with you before you join.
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 am aged 18 or older.
- I have been diagnosed with narcolepsy type 1 (narcolepsy with cataplexy).
- I regularly experience daytime sleepiness and sudden muscle weakness.
- I am willing to visit the clinic for sleep tests and health monitoring.
- I am able to take study tablets every day as instructed.
What does participation involve?
If you decide to take part, you will be randomly assigned to take either TAK-360 or a placebo (a dummy tablet) each day. The main study treatment period lasts for around six weeks, though there will be visits beforehand for health checks and follow-up checks afterwards. You will visit a specialist clinic to have regular health checks, blood tests, and sleep assessments. These tests include sitting in a quiet, dark room to see how easily you can stay awake, filling out questionnaires about your daytime tiredness, and keeping a diary of any cataplexy episodes you experience.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is a placebo and why is it used?
A placebo is a pill that looks and tastes just like the real medicine but contains no active drug. It helps doctors see if any health improvements or side effects are truly caused by the study medicine.
Can I choose whether I receive the study drug or the dummy pill?
No. A computer randomly chooses your group by chance, like flipping a coin. Neither you nor your study doctor will know which treatment you are receiving during the trial.
How long will I be involved in the study?
The main treatment phase lasts around six weeks, but you will also have screening visits before starting and follow-up safety checks after the treatment ends.
Will taking part cost me anything?
No, all study tablets, health checks, and doctor visits are provided free of charge. Most clinical trials also offer help to cover your travel expenses.
What happens if I want to stop taking part?
You are free to leave the trial at any point. Deciding to withdraw will never affect your relationship with your doctors or the standard of care you receive on the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.