RecruitingPHASE3INTERVENTIONAL

Lemborexant Treatment of Insomnia Linked to Epilepsy

This research study is investigating a new medicine called Lemborexant. It aims to find out if Lemborexant can help people with epilepsy who also have trouble sleeping. Many people with epilepsy experience sleep problems, which can affect their quality of life. The study will compare Lemborexant with a placebo (a dummy pill that has no medicine in it) to see if it genuinely improves sleep. This is a Phase 3 trial, meaning it's a large-scale study after earlier safety tests. The goal is to provide new information that might lead to a new treatment option for managing sleep difficulties in people with epilepsy.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Manitoba

Enrolment target

Start

29 Oct 2024

Estimated completion

18 Apr 2027

Epilepsy Sleep

What is this study about?

This research is looking into a new medicine called Lemborexant. The main goal is to see if Lemborexant can help people with epilepsy who also find it hard to sleep well. We know that experiencing epilepsy can sometimes lead to difficulties with sleep, which can make daily life feel even harder. This study wants to find a way to improve sleep for these individuals.

To do this, some people in the study will receive Lemborexant, while others will receive a placebo. A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This helps researchers figure out if any improvements seen are truly due to the medicine or if they might happen naturally or because people expect to feel better. Neither you nor your doctor will know whether you are taking Lemborexant or the placebo.

The findings from this study are very important. If Lemborexant proves to be safe and effective, it could become a new treatment option to help people with epilepsy get the better sleep they need. Improving sleep can have a big positive impact on overall well-being and quality of life for those living with epilepsy.

Key takeaways

The study tests a new drug, Lemborexant, for sleep problems in epilepsy.
It aims to improve sleep for people with epilepsy.
The study compares Lemborexant to a dummy pill (placebo).
It's a large-scale study (Phase 3) after earlier safety tests.
Participation involves regular clinic visits and taking study medication.
You can leave the study at any time.

Who may be eligible?

To join this study, you must have a type of epilepsy that affects your sleep. Also, if you are a woman who could become pregnant, you would need to use effective contraception during the study to prevent pregnancy.

There are several reasons why someone might not be able to join. For example, if your epilepsy medication has changed recently (within the last month before or during the study), you wouldn't be eligible. Also, if you have certain liver problems, breathing difficulties, or a history of sleepwalking or other complex sleep behaviours, you wouldn't be able to take part.

Other reasons for not being able to join include having certain rare inherited sugar-related conditions, a history of drug dependence, severe mental health conditions like depression with suicidal thoughts, or a diagnosis of narcolepsy (a condition that causes sudden sleep attacks). If you are pregnant or breastfeeding, you also cannot 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.

Do you have epilepsy that affects your sleep?
Have you been on the same epilepsy medication for at least one month?
Are you able to use effective contraception if you are a woman?
Do you have any serious liver or breathing problems?
Have you ever had serious sleepwalking or other complex sleep behaviours?
Do you have a diagnosis of narcolepsy or severe mental health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the clinic regularly. At these visits, doctors and nurses would check your health, ask you questions about your sleep and epilepsy, and carry out some tests. You would be given either Lemborexant or a placebo to take as instructed. It's important to take the medication exactly as directed. The study would involve several follow-up appointments to monitor your progress and make sure you are doing well. The total length of your involvement in the study would be explained to you, including how often you would need to attend appointments and for how long.

Potential risks and benefits

A potential benefit of joining this study is that Lemborexant might improve your sleep if you have epilepsy. However, there's no guarantee, as some participants will receive a placebo. All medicines can have side effects, and Lemborexant may cause some you don't expect. The study team will explain any known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Duke University
Verified postcode
Durham, United States· Not yet recruiting
Health Sciences Centre
Verified postcode
Winnipeg, Canada· Recruiting

Common questions

What is Lemborexant?

Lemborexant is a new medicine being tested to see if it can help people with epilepsy who also have trouble sleeping.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects.

Will I know if I'm taking the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving Lemborexant or the placebo.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

How long will the study last for me?

The total length of your participation in the study will be clearly explained to you by the research team if you are eligible.

How to find out more

Marcus C Ng, MD, FRCPC

letoile@umanitoba.ca 204-787-2684 Official trial record

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