A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy
Narcolepsy is a long-term brain condition that causes people to feel suddenly and overwhelmingly tired during the day. Some people also experience sudden muscle weakness, known as cataplexy. This clinical trial is testing a new investigational tablet called E2086 to see if it can help adults with narcolepsy stay awake and manage their symptoms. Participants will take either the study medicine or a dummy pill (placebo) once a day for four weeks. Because this is a double-blind trial, neither you nor the study team will know which tablet you receive until the trial finishes. Throughout the study, doctors will measure how long you can stay awake in quiet rooms, check your blood pressure and heart rhythm, and see if your daily sleepiness improves. The goal is to find out whether E2086 is effective and safe to use.
At a glance
What is this study about?
Narcolepsy is a rare, lifelong condition that affects the brain's ability to regulate the normal sleep-wake cycle. People living with narcolepsy often feel intensely sleepy during the day, may fall asleep without warning, and can experience broken sleep at night. Many also experience cataplexy, which is a sudden loss of muscle control triggered by strong emotions such as laughter or surprise. Current treatments do not work for everyone, which is why researchers are looking for new options.
This trial is testing an experimental medicine named E2086. It is designed to help boost daytime alertness and reduce episodes of muscle weakness. Researchers are comparing E2086 against a placebo, which is a dummy pill that looks identical but contains no active medicine. Using a placebo helps doctors prove whether any improvements are truly caused by E2086.
During the trial, doctors will use special daytime tests where you sit in a quiet, dimly lit room to measure how well you can resist falling asleep. They will also look closely at your heart health, blood pressure, and routine blood tests to make sure the medicine does not cause unwanted health problems. Finding new treatments could help people with narcolepsy lead safer, more alert daily lives.
Key takeaways
- The trial tests a new medicine called E2086 for adults with narcolepsy type 1 or type 2.
- Participants take either E2086 or a dummy pill (placebo) daily for four weeks.
- The study checks whether the drug improves daytime alertness and reduces muscle weakness.
- Safety checks include blood pressure tracking, heart traces, and routine blood tests.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with narcolepsy. This includes both narcolepsy type 1 (which includes sudden muscle weakness or cataplexy) and narcolepsy type 2 (which does not include cataplexy).
To take part, you will need to be in generally stable health apart from your narcolepsy. You must be willing to attend regular clinic appointments, take study tablets every day, and complete sleep and health assessments.
You may not be eligible if you have certain other untreated medical conditions, heart problems, or if you are taking specific medications that cannot be safely paused or combined with the study drug. The trial doctor will review your full medical history 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 a confirmed diagnosis of narcolepsy (type 1 or type 2).
- I am able to attend clinic visits and take study tablets daily for four weeks.
- I am willing to undergo daytime sleep tests and heart monitoring.
- I am happy to discuss my current medications with the research team.
What does participation involve?
Taking part in this study lasts for several weeks. You will take study tablets every day for four weeks. Half of the participants will receive the active study medicine E2086, and half will receive a matching dummy tablet (placebo).
You will need to visit the study clinic several times. During these visits, you will take part in daytime wakefulness tests, where staff measure how long you can stay awake. You will also fill out questionnaires about your daytime sleepiness, have blood and urine tests, and have your heart checked using an electrocardiogram (ECG).
Additionally, you will wear a blood pressure monitor that takes regular readings over a 24-hour period. The study team will closely monitor your physical health and mood throughout your time on the trial.
Potential risks and benefits
Locations (4)
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is a placebo and why is it used?
A placebo is a harmless dummy pill that looks exactly like the real medicine. It helps researchers see if any changes in symptoms are truly caused by the study drug rather than chance.
Will I know if I am taking the real medicine?
No. This is a double-blind trial, meaning neither you nor your study doctor will know whether you are taking E2086 or the placebo until the trial ends.
What is the stay-awake test?
It is called a Maintenance of Wakefulness Test. You sit comfortably in a quiet, dim room several times during the day while sensors measure how easily you can stay awake.
Do I have to pay to take part?
No, clinical trials are free to join. Study visits and tests are covered, and you may be offered help with travel costs to and from the clinic.
Can I stop taking part if I change my mind?
Yes. You can leave the study at any point without giving a reason, and your regular doctor will continue to support your care as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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