AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

This important study, named ALKS 2680, is looking for adult volunteers who have Narcolepsy Type 2. The main goal is to find out if this new medicine can help people feel less sleepy during the day. Participants will be given either the new medicine or a 'dummy' pill (placebo) which looks exactly the same, but contains no active drug. This helps us fairly compare how well the medicine works. We will closely monitor how sleepy participants feel using a special scale, and also look at how long they can stay awake. The study also explores how the medicine affects their daily lives, as reported by the participants themselves. This is a crucial Phase 3 trial to learn more about the medicine's effectiveness and safety.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Alkermes Inc.

Enrolment target

Start

04 Jun 2026

Narcolepsy Type 2

What is this study about?

This research study is focused on a condition called Narcolepsy Type 2. This type of narcolepsy mainly causes excessive daytime sleepiness, which can make it hard to concentrate, stay awake, and carry out daily activities. The study is investigating a new medication, ALKS 2680, to see if it can help reduce this sleepiness and generally improve how people with Narcolepsy Type 2 feel.

To make sure the study gives reliable results, some participants will receive the new medicine while others will receive a 'placebo'. A placebo looks identical to the actual medicine but doesn't contain any active ingredients. This is a common and important practice in medical research – it helps scientists clearly see if any improvements are truly due to the new medicine and not just other factors. Neither you nor your study doctor will know if you are taking the active medicine or the placebo, which helps keep the trial fair and unbiased.

Over 12 weeks, the research team will regularly check how your sleepiness changes using a standard questionnaire called the Epworth Sleepiness Scale. They will also measure how long you can stay awake during specific tests and ask you about your own experiences and feelings. By collecting all this information, the study aims to confirm if ALKS 2680 is an effective and safe treatment option for adults living with Narcolepsy Type 2.

Key takeaways

The study is testing a new medicine (ALKS 2680) for Narcolepsy Type 2.
It aims to reduce daytime sleepiness and improve daily life.
Participants will receive either the new medicine or a placebo (dummy pill).
It's a 12-week study with regular check-ups and assessments.
Only adults (18+) with Narcolepsy Type 2 can join.
Your participation helps advance understanding and treatments for Narcolepsy Type 2.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with Narcolepsy Type 2. Both men and women are welcome to participate. Usually, specific medical conditions or medications might affect whether you can join, but the detailed criteria would be discussed with you by the study team.

It's important to know that before you can join, a doctor on the study team will carefully check your health and medical history. This is to make sure the study is safe for you and that the results collected will be useful for understanding how the new medicine works for people with Narcolepsy Type 2.

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?
Have you been diagnosed with Narcolepsy Type 2?
Are you comfortable with the possibility of receiving a 'dummy' pill (placebo)?
Are you able to attend regular study appointments over 12 weeks?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the new medicine (ALKS 2680) or a placebo (a dummy pill). You won't know which one you're getting, and neither will your study doctor. You'll take the assigned medication regularly over a 12-week period. During this time, you'll have several visits to the clinic for assessments. These visits will involve answering questions about your sleepiness and how you're feeling, and undergoing specific tests to measure your wakefulness. There will also be follow-up checks after the 12 weeks to see how you're doing. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained before you agree to join.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might help reduce your excessive daytime sleepiness. You'll also receive regular medical checks and contribute to valuable research that could help others with Narcolepsy Type 2 in the future. However, there are potential risks, as with any medication, including possible side effects from ALKS 2680, or you might receive the placebo and not experience any direct benefit. The study team will explain all known side effects and monitor you closely. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Netherlands
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Unverified
Belgium
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Unverified
Italy
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Unverified
France

Common questions

What is Narcolepsy Type 2?

Narcolepsy Type 2 is a long-term sleep disorder where you feel very sleepy during the day, even if you had enough sleep at night. It's different from Type 1 because it doesn't usually cause sudden muscle weakness (cataplexy).

What does 'placebo-controlled' mean?

It means some participants will get the actual medicine and others will get a 'dummy' pill that looks the same but has no medicine in it. This helps researchers compare the effects fairly.

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

No, during the study, neither you nor your doctor will know whether you're receiving the active medicine or the placebo. This is to make sure the study results are as accurate as possible.

How long will I be in the study?

The main treatment period is 12 weeks, during which you'll take the study medicine or placebo. There will also be initial checks and follow-up visits, so the total time will be longer and will be clearly explained to you.

What is the Epworth Sleepiness Scale?

It's a simple questionnaire that asks how likely you are to doze off or fall asleep in different everyday situations. It helps doctors understand how sleepy you feel during the day.