RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

This study is investigating a new medication, a tablet called ALKS 2680, for individuals diagnosed with Idiopathic Hypersomnia. This condition causes people to feel excessively sleepy during the day, even after a full night's sleep. The main goal of this research is to check if ALKS 2680 is safe for people to take and if it can help reduce this troublesome daytime sleepiness. To understand its effects, some participants will receive ALKS 2680, while others will be given a 'placebo' – a dummy tablet that looks the same but contains no active medicine. This allows researchers to compare the new tablet's effects against not receiving the active drug. The study is currently in Phase 2, which means it's still in the earlier stages of drug development.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Alkermes, Inc.

Enrolment target

Start

22 May 2025

Estimated completion

01 Jun 2026

Idiopathic Hypersomnia

What is this study about?

This study is designed to learn more about a new medication, ALKS 2680, for a sleep condition called Idiopathic Hypersomnia. People with Idiopathic Hypersomnia often feel extremely sleepy during the day, no matter how much sleep they get at night. This can make it hard to do everyday activities.

Researchers want to find out two main things: first, if ALKS 2680 is safe for people to take, and second, if it can help reduce the amount of daytime sleepiness experienced by those with Idiopathic Hypersomnia. To do this, some people in the study will receive the new tablet, while others will receive a 'placebo,' which is a tablet that looks identical but doesn't contain any active medication. By comparing the results from both groups, the researchers can understand how effective ALKS 2680 might be.

Understanding how new treatments work and if they are safe is very important for people living with conditions like Idiopathic Hypersomnia. This study aims to gather important information that could potentially lead to new ways to help manage this challenging condition and improve daily life for those affected.

Key takeaways

The study tests a new tablet (ALKS 2680) for Idiopathic Hypersomnia.
It aims to check safety and reduce daytime sleepiness.
Participants will receive either the active drug or a dummy tablet (placebo).
Participation involves clinic visits, health checks, and keeping a sleep diary.
You must be 18-70 years old with a confirmed Idiopathic Hypersomnia diagnosis.
The information gained could help others with Idiopathic Hypersomnia in the future.

Who may be eligible?

To join this study, you must be between 18 and 70 years old. You need to have been officially diagnosed with Idiopathic Hypersomnia within the last 10 years, based on specific sleep tests. It's important that you're willing to follow all the study rules, including using contraception if needed, keeping a diary, and wearing a special movement tracker.

There are also some reasons why you might not be able to join. For example, if you have another significant sleep problem or any other serious ongoing health issues that might affect your safety or the study results. If you're currently pregnant, breastfeeding, or planning to become pregnant during the study, you won't be able to take part. Also, if you're already in another clinical study or have used an experimental drug in the last month, you won't be eligible.

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 between 18 and 70 years old?
Have you been officially diagnosed with Idiopathic Hypersomnia within the last 10 years?
Are you able to regularly attend clinic appointments and follow study instructions?
Do you have any other significant ongoing health conditions or sleep disorders?
Are you currently pregnant, breastfeeding, or planning to become pregnant during the study?
Are you currently taking part in another medical study or have you used an experimental drug recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several appointments at a clinic. These visits will involve various health checks, sleep tests, and answering questions about your sleepiness. You will be given either the new study medication (ALKS 2680) or a placebo (a dummy tablet) to take. You won't know which one you're receiving, nor will the study team, until the study is over. You'll need to keep a diary of your sleep and daily activities and wear a small device (called an actigraphy device) that tracks your movement. You'll have regular follow-up appointments to monitor your health and how you're responding to the medication. The total length of your participation in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study means there's a chance you might experience some benefits, such as improvements in your daytime sleepiness, or you might not. There's also a possibility of experiencing side effects from the study medication, which the study team will discuss with you. Because you might receive a placebo, you may not get any direct medical benefit from the study drug itself. However, by participating, you contribute valuable information that can help others in the future. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (48)

Alkermes Investigator Site
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Cullman, United States· Recruiting
Alkermes Investigator Site
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Phoenix, United States· Recruiting
Alkermes Investigator Site
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Little Rock, United States· Recruiting
Alkermes Investigator Site
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Los Angeles, United States· Recruiting
Alkermes Investigator Site
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Redwood City, United States· Recruiting
Alkermes Investigator Site
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San Francisco, United States· Recruiting
Alkermes Investigator Site
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Colorado Springs, United States· Recruiting
Alkermes Investigator Site
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Brandon, United States· Recruiting
Alkermes Investigator Site
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Miami, United States· Recruiting
Alkermes Investigator Site
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Winter Park, United States· Recruiting
Alkermes Investigator Site
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Atlanta, United States· Recruiting
Alkermes Investigator Site
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Macon, United States· Recruiting

Common questions

What is Idiopathic Hypersomnia?

It's a sleep disorder where you feel extremely sleepy during the day, even after sleeping for a long time at night.

What is a 'placebo'?

A placebo is a dummy tablet that looks like the real medicine but doesn't contain any active ingredients. It helps researchers compare the effects of the new drug.

Will I know if I'm getting the active drug or the placebo?

No, neither you nor the study team will know which you are receiving until the study is finished. This is called 'blinding' and helps ensure fair results.

Are there any costs involved for me?

Usually, clinical trials cover study-related costs. This will be fully explained to you by the study team.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, for any reason, and your regular medical care will not be affected.

How to find out more

Director, Global Clinical Services

clinicaltrials@alkermes.com 888-235-8008 (US Only) Official trial record

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