Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

This research study is investigating a new medication, ALKS 2680, for individuals diagnosed with Narcolepsy Type 2. The main goal is to understand if this new drug is safe to use and how well it helps reduce the excessive daytime sleepiness commonly experienced with this condition. Participants will be divided into groups, some receiving different doses of ALKS 2680 and others a placebo (a dummy pill with no active medicine). This comparison helps researchers determine the drug's effectiveness. We'll be closely monitoring how participants' sleepiness changes over eight weeks and looking at other health measures to check for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Alkermes Inc.

Enrolment target

124

Start

13 Mar 2025

Narcolepsy Type 2

What is this study about?

This clinical trial is designed to see if a new medicine, called ALKS 2680, can help people who have Narcolepsy Type 2. Narcolepsy Type 2 is a condition that makes people feel very sleepy during the day, even after a full night's sleep. This can make everyday activities challenging and can often be difficult to manage.

The main aim of this study is to look at how safe ALKS 2680 is and how well it works to reduce daytime sleepiness. We will be comparing different amounts (doses) of ALKS 2680 to see which might be most effective. Some volunteers will receive the new medicine, while others will be given a placebo, which looks just like the study medicine but contains no active ingredients. This is a common way to test new drugs reliably.

Researchers will be carefully tracking changes in how sleepy participants feel and how easily they can stay awake during the day over an 8-week period. They will also be checking various health markers, like blood tests, heart readings, and looking for any side effects, to make sure the treatment is as safe as possible.

Key takeaways

This study evaluates a new drug, ALKS 2680, for Narcolepsy Type 2.
It aims to check the safety and how well it reduces daytime sleepiness.
Participants will receive either different doses of ALKS 2680 or a placebo.
The main treatment period is 8 weeks, with close monitoring for effects and side effects.
Results could help improve future treatments for Narcolepsy Type 2.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other criteria.

This study is open to both men and women. The researchers want to include a wide range of people to make sure the results are relevant to everyone who might one day benefit from this new treatment.

Beyond age and gender, there will be other specific health requirements that your doctor will check. These are in place to make sure the study medication is safe for you and that the study results are clear and accurate.

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 at least 18 years old?
Have you been diagnosed with Narcolepsy Type 2?
Are you comfortable visiting a clinic regularly for assessments?
Do you understand that you might receive a placebo?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first go through a screening process to check if you're suitable for the study. This would involve medical checks and answering questions about your health. If you qualify, you'd be given either ALKS 2680 or a placebo, which you'd take as instructed by the study team.

During the study, you would have regular visits to the clinic over a period of several weeks. At these visits, the research team would carry out different assessments. These might include tests to measure your alertness, questionnaires about how sleepy you feel, blood tests, checks of your vital signs (like blood pressure and heart rate), and possibly ECGs (heart rhythm tests). The team would be there to support you and answer any questions.

After the main treatment period, there will be an 'open-label' period, where all participants will have the option to receive ALKS 2680, and the study team will continue to monitor your health. The total duration of your involvement, including all visits and follow-ups, would be explained in detail before you agree to join.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and helping advance medical knowledge for others with Narcolepsy Type 2. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not improve your symptoms. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Spain
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Unverified
Czechia
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Unverified
France
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Unverified
Italy
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Unverified
Netherlands
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Unverified
Belgium

Common questions

What is Narcolepsy Type 2?

It's a long-term condition that causes overwhelming daytime sleepiness and can make it hard to stay awake and alert during the day.

What is ALKS 2680?

It's a new medication being tested to see if it can help reduce the sleepiness caused by Narcolepsy Type 2.

What is a placebo?

A placebo is a dummy pill that looks like the study medicine but has no active drug in it. It helps compare the new medicine's effects accurately.

How long will the study last?

The main part of the study involves taking the medication for 8 weeks, with regular visits. There might also be a longer 'open-label' period where everyone can receive the active drug.

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

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting the active drug and who is getting the placebo until after the study is over.