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Long-Term Study on the Safety and Effects of ALKS 2680 for Patients with Narcolepsy Type 1 and Type 2

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called ALKS 2680 in individuals with narcolepsy, a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The study includes participants with both Narcolepsy Type 1 and Type 2. The purpose of the study is to evaluate the safety and how well people tolerate ALKS 2680 over a long period.

Participants in the study will take ALKS 2680 in the form of a tablet, which is taken by mouth. The study will monitor participants for any side effects and changes in their health. This includes regular checks of vital signs, such as heart rate and blood pressure, and assessments of sleepiness and cataplexy symptoms. The study will also use tests like the Epworth Sleepiness Scale to measure changes in sleepiness and the Maintenance of Wakefulness Test to see how long participants can stay awake during the day.

The study is designed to last for several years, allowing researchers to gather information on the long-term effects of ALKS 2680. Participants will be closely monitored throughout the study to ensure their safety and to collect data on how the medication affects their narcolepsy symptoms over time. This research aims to provide valuable insights into the potential benefits and risks of using ALKS 2680 as a treatment for narcolepsy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You must have completed a previous study with ALKS 2680 and shown improvement in narcolepsy symptoms.

  2. Step 2

    Medication administration

    You will take the medication ALKS 2680 in the form of a tablet. The medication is taken orally, which means you swallow it.

    The dosage, frequency, and duration of administration will be explained to you by the study team.

  3. Step 3

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the medication.

    These assessments include checking vital signs, laboratory tests, and an electrocardiogram (ECG), which measures the heart's electrical activity.

  4. Step 4

    Monitoring sleep and symptoms

    Your sleep patterns and symptoms will be monitored using tests like the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).

    For those with narcolepsy type 1, changes in the frequency of cataplexy episodes will also be tracked.

  5. Step 5

    Safety evaluations

    The study will include evaluations for any side effects or adverse events that may occur during the treatment.

    A specific scale, the Columbia-Suicide Severity Rating Scale (C-SSRS), will be used to assess your mental health and well-being.

  6. Step 6

    Completion of the study

    The study is expected to continue until December 31, 2027. You will be informed about the completion process and any follow-up required.

    Your participation will contribute to understanding the long-term effects of ALKS 2680 in treating narcolepsy.

Who can join the trial?

8 criteria

  • The patient must be diagnosed with narcolepsy Type 1 or Type 2. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness and sudden sleep attacks.
  • The patient must be willing and able to give their agreement to participate in the study, which is called informed consent.
  • The patient must have completed a previous study with the medication ALKS 2680 for narcolepsy.
  • The patient must be willing and able to follow the study rules, which include certain lifestyle habits and using birth control methods if applicable.
  • The patient must be willing and able to stop taking any other medications for narcolepsy symptoms, such as excessive daytime sleepiness (EDS) and cataplexy, if required by the study.
  • The patient must have shown improvement in narcolepsy symptoms during a previous study with ALKS 2680.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered part of a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

9 criteria

  • Patients with any other sleep disorders besides narcolepsy cannot participate.
  • Individuals with a history of severe allergic reactions to medications are excluded.
  • Participants who are currently using medications that affect the central nervous system, which includes the brain and spinal cord, are not eligible.
  • People with significant heart problems, such as uncontrolled high blood pressure or recent heart attack, cannot join the study.
  • Individuals with severe liver or kidney disease are excluded from participation.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Participants with a history of drug or alcohol abuse within the past year are not eligible.
  • Anyone who has participated in another clinical trial within the last 30 days is excluded.
  • Individuals with any condition that, in the opinion of the study doctor, makes participation unsafe or not in the best interest of the participant are not eligible.
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Investigated drugs

ALKS 2680 is a medication being studied for its effects on people with narcolepsy, a condition that causes excessive sleepiness and sudden sleep attacks. This medication is being tested to see how safe it is for long-term use and how well people can tolerate it. The study also aims to find out if the medication can help reduce the symptoms of narcolepsy over time. Participants in the trial will receive this medication to see if it can improve their condition and help them manage their symptoms better.

What is already known about the treatment

ALKS 2680 – ALKS 2680 is a medication currently being studied for its potential to help people with narcolepsy, a condition that causes excessive sleepiness and sudden sleep attacks. It is administered in an open-label, long-term extension study to assess its safety, tolerability, and how well it continues to work over time. The main goal of this study is to ensure that the medication is safe and can be tolerated by patients with narcolepsy types 1 and 2. While the exact mechanism of action at the molecular level is not detailed here, the study focuses on understanding how this medication can improve the quality of life for those affected by narcolepsy.

Investigated diseases

  • Narcolepsy Type 1

    Narcolepsy Type 1 is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. It often includes cataplexy, which is a sudden loss of muscle tone triggered by strong emotions. People with this condition may experience disrupted nighttime sleep and vivid hallucinations as they fall asleep or wake up. Sleep paralysis, a temporary inability to move or speak while falling asleep or upon waking, is also common. The disorder is linked to a deficiency of hypocretin, a brain chemical that regulates wakefulness. Symptoms typically begin in childhood or adolescence and can significantly impact daily activities.

  • Narcolepsy Type 2

    Narcolepsy Type 2 is a sleep disorder similar to Type 1 but without cataplexy. It is characterized by excessive daytime sleepiness and sudden sleep attacks. Individuals may experience fragmented nighttime sleep and vivid dreams or hallucinations as they fall asleep or wake up. Sleep paralysis can also occur, causing temporary inability to move or speak. Unlike Type 1, hypocretin levels are usually normal in Type 2. Symptoms often start in adolescence or early adulthood and can interfere with daily functioning.

Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519822-18-00Protocol codeALKS 2680-301Estimated enrolment739 patientsSponsorAlkermes Inc.

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