AuthorisedTherapeutic confirmatory (Phase III)Interventional

OPEN-LABEL SAFETY STUDY OF A 1-YEAR 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION

This important study is testing a medication called tasimelteon, also known as Hetlioz, to understand its safety when used by blind individuals who cannot perceive any light and struggle with a condition called Non-24-Hour Sleep-Wake Disorder. This condition means their body clock can't keep a regular sleep schedule, causing sleep problems day and night. For a full year, participants will take a 20mg dose of the medicine. During this time, the research team will closely monitor for any side effects, changes in their overall health, and how they feel the treatment is affecting their sleep and daily life. This is a Phase III study, which means the medicine has already been through earlier testing and is now being looked at more widely for its safety.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Vanda Pharmaceuticals Inc.

Enrolment target

140

Start

03 Dec 2024

Non-24 Hour Sleep-Wake Disorder

What is this study about?

This study is about a medicine called tasimelteon, also known as Hetlioz. It's being tested specifically for people who are blind, meaning they can't see any light at all, and who have a sleep problem called Non-24-Hour Sleep-Wake Disorder, often shortened to N24HSWD. Picture it like this: most people's bodies have an internal clock that tells them when to be awake and when to sleep, usually linked to daylight. For people with N24HSWD, especially those who are completely blind, this clock can get out of sync with the normal 24-hour day. This means they might feel wide awake in the middle of the night and sleepy during the day, making it very hard to lead a regular life.

The main goal of this study is to see how safe the medicine tasimelteon is for people with N24HSWD over a whole year. Doctors will be checking very carefully for any side effects the medicine might cause. They'll also look at things like changes in blood pressure, heart health (using an ECG, which checks heart rhythm), and overall physical health. This information is key to making sure the medicine can be used safely to help people manage this challenging sleep condition.

Beyond just safety, the study also wants to understand if the medicine helps people feel better. They'll be asking participants how much their sleep has improved at night, if they're taking fewer naps during the day, and overall how they feel the treatment has changed their sleep and daily life. This helps researchers understand both the safety and potential benefits of tasimelteon for those living with N24HSWD.

Key takeaways

The study is testing a medication called tasimelteon (Hetlioz) for its safety.
It's for adults who are completely blind and have Non-24-Hour Sleep-Wake Disorder.
Participants will take the medicine daily for one year.
Doctors will closely check for any side effects and monitor overall health.
They'll also ask participants how their sleep and daily life are affected.
Participation is voluntary and you can leave at any time.

Who may be eligible?

This study is looking for adults aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part.

To be eligible, participants must be completely blind and unable to see any light whatsoever. They should also have a diagnosis of Non-24-Hour Sleep-Wake Disorder, which is a condition where your body's sleep-wake cycle isn't aligned with the 24-hour day because you can't sense light.

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 old or older?
Are you completely blind, meaning you cannot see any light?
Have you been diagnosed with Non-24-Hour Sleep-Wake Disorder?
Are you willing to take the study medicine for one year?
Are you able to attend regular study visits for health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking the study medicine, tasimelteon (Hetlioz) at a 20mg dose, every day for a full year. Throughout this year, you would have regular visits with the study team. During these visits, doctors and nurses would perform various checks to monitor your health and how you are responding to the medication. This would include checking your vital signs (like blood pressure and heart rate), taking blood and urine samples for lab tests, performing electrocardiograms (ECGs) to check your heart, and having physical examinations. You would also be asked to share how you feel the medicine is affecting your nighttime sleep and daytime energy levels. The total duration of your participation in the study, including all follow-up, would be about one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that the study medication, tasimelteon, might help to regulate your sleep patterns and improve your quality of life if you have Non-24-Hour Sleep-Wake Disorder. Doctors will be closely monitoring your health for any side effects, including serious ones like changes in mood, heart problems, or other unexpected reactions. You are completely free to withdraw from the study at any time, for any reason, without needing to explain why, and this will not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Non-24-Hour Sleep-Wake Disorder (N24HSWD)?

It's a sleep problem where your body's internal clock doesn't follow a regular 24-hour day, often causing you to feel sleepy at unusual times and awake at night. It's common in people who are totally blind because they can't sense light.

What is tasimelteon (Hetlioz)?

It's a medication that has been developed to help regulate the sleep-wake cycle, especially for people with Non-24-Hour Sleep-Wake Disorder.

Why is this study only for people who are totally blind?

The study focuses specifically on blind individuals who cannot see any light, as their lack of light perception directly contributes to Non-24-Hour Sleep-Wake Disorder, and the medication works on pathways affected by light.

What kind of tests will I have during the study?

You'll have regular health checks, including blood tests, urine tests, ECGs (to check your heart), physical exams, and doctors will ask how you're feeling and sleeping.

Will I know if the medicine is working for me?

The study team will regularly ask you about your sleep patterns, how you feel during the day, and if you notice any changes in your overall well-being. This helps to see if the medicine is making a difference for you.