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 1

This important study is looking into a new medicine called ALKS 2680 for adults who have Narcolepsy Type 1. Narcolepsy Type 1 is a condition that makes people feel very sleepy during the day and can cause sudden muscle weakness (cataplexy). The main goal is to find out if ALKS 2680 helps people feel less sleepy, using a special questionnaire called the Epworth Sleepiness Scale. Researchers will also check how safe the medicine is. To do this, some participants will receive the new medicine, while others will receive a 'dummy' medicine (placebo) that looks the same but contains no active drug. This helps scientists compare the effects fairly.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Alkermes Inc.

Enrolment target

Start

02 Jun 2026

Narcolepsy Type 1

What is this study about?

This study is focused on a medical condition called Narcolepsy Type 1. People with Narcolepsy Type 1 often struggle with extreme tiredness during the day, which can make it hard to concentrate or stay awake. They might also experience 'cataplexy,' which is a sudden loss of muscle control often triggered by strong emotions like laughter or surprise. This can be very disruptive to daily life.

The research team is testing a new medicine called ALKS 2680. The main purpose of the study is to see if this new medicine can help people with Narcolepsy Type 1 feel less sleepy during the day. They will measure changes in sleepiness using a widely recognised questionnaire called the Epworth Sleepiness Scale over 12 weeks. They will also be very careful to check for any side effects and make sure the medicine is safe.

The study is designed as a 'double-blind, placebo-controlled' trial. This means that neither you nor your study doctor will know whether you are receiving the new medicine (ALKS 2680) or a 'placebo' (a dummy pill with no active drug). This is a standard and important way to ensure the results are accurate and unbiased, so we can truly understand if the new medicine is working.

Key takeaways

This study is testing a new medicine (ALKS 2680) for Narcolepsy Type 1.
It aims to see if the medicine reduces daytime sleepiness and is safe.
Participants will receive either the new medicine or a placebo (dummy pill).
Neither you nor your doctor will know which you are receiving.
The study lasts for 12 weeks of treatment, with regular clinic visits.
It's for adults aged 18 and above with Narcolepsy Type 1.

Who may be eligible?

This study is for adults aged 18 and over. Both men and women can take part.

To be considered for this study, you must have a confirmed diagnosis of Narcolepsy Type 1.

There will be other, more detailed criteria that the study doctors will discuss with you. These are in place to make sure the study includes people who are most likely to benefit from or safely participate in the trial, and to ensure the results of the study are clear and reliable.

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?
Do you have a diagnosis of Narcolepsy Type 1?
Are you able to attend regular clinic appointments?
Are you willing to take study medication as directed?
Are you comfortable with the possibility of receiving a placebo instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the study clinic regularly over a period of 12 weeks. At these visits, you would have check-ups with the study doctor or nurse, answer questionnaires about your sleepiness and other symptoms, and you might have some special sleep tests. You would also take the study medicine or placebo as instructed. Throughout the study, the team will closely monitor your health and any side effects you might experience. After the 12 weeks of treatment, there will likely be follow-up appointments to check on you.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medicine before it's widely available and extra medical care. However, there are also potential risks, as new medicines can have unexpected side effects. You might receive the placebo, meaning you wouldn’t get the active medicine. The research team will explain all known side effects. It’s important to remember that participating is a choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your 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
Italy
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Unverified
France
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Unverified
Netherlands
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Unverified
Spain

Common questions

What is Narcolepsy Type 1?

Narcolepsy Type 1 is a long-term brain condition that causes overwhelming daytime sleepiness and can lead to sudden muscle weakness called cataplexy, often triggered by strong emotions.

What is ALKS 2680?

ALKS 2680 is a new medicine being tested to see if it can help reduce sleepiness in adults with Narcolepsy Type 1.

What does 'placebo-controlled' mean?

It means some people will get the new medicine, and others will get a 'dummy' pill (placebo) that looks the same but has no active drug. This helps us see if the new medicine truly works.

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

No, neither you nor your study doctor will know what you are receiving. This is called 'double-blind' and helps ensure the study results are fair.

How long will the study last for me?

The main part of the study involves taking the medicine for 12 weeks, with regular visits and follow-ups before and after this period.