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Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy 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 a condition known as Narcolepsy Type 2, which is a sleep disorder that causes excessive daytime sleepiness. The study will evaluate a treatment called ALKS 2680, which is taken in the form of a tablet. The purpose of the study is to assess the safety and effectiveness of ALKS 2680 in managing symptoms of narcolepsy, particularly excessive daytime sleepiness.

Participants in the study will be randomly assigned to receive either ALKS 2680 or a placebo. The study will have both a double-blind period, where neither the participants nor the researchers know who is receiving the actual medication, and an open-label period, where everyone knows who is receiving the treatment. The study will last for a total of eight weeks, during which the effects of the medication on sleepiness will be closely monitored.

The main goal is to determine how ALKS 2680 affects the ability to stay awake during the day. Participants will undergo various assessments to measure changes in their sleepiness levels and overall health. The study aims to provide valuable information on the potential benefits of ALKS 2680 for individuals with Narcolepsy Type 2.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomized double-blind treatment period

    Participants will be randomly assigned to receive either ALKS 2680 or a placebo. The medication will be administered orally in the form of a tablet.

    The dosage and frequency of administration will vary as part of the study's dose-range-finding approach. This period aims to evaluate the safety and effectiveness of the medication.

  2. Step 2

    Open-label period

    After the double-blind treatment period, all participants will receive ALKS 2680 in an open-label format. This means that both the participants and the researchers will know that the active medication is being administered.

    The purpose of this period is to further assess the medication's safety and effectiveness over time.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo various assessments to monitor their response to the treatment. These assessments include measuring changes in the Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) and changes in the Epworth Sleepiness Scale (ESS) score.

    Additional evaluations will include clinical laboratory assessments, vital signs, safety electrocardiograms (ECGs), and the Columbia-Suicide Severity Rating Scale (C-SSRS).

  4. Step 4

    Completion of study

    The study is expected to conclude by August 15, 2025. Participants will have contributed valuable data to help understand the safety and effectiveness of ALKS 2680 for individuals with narcolepsy type 2.

Who can join the trial?

7 criteria

  • You must be between 18 and 70 years old.
  • You need to agree to participate in the study and sign a consent form.
  • Your Body Mass Index (BMI) should be between 18 and 40. BMI is a measure of body fat based on your height and weight.
  • If you are taking medication for narcolepsy symptoms and it's not working well or causing side effects, you should be able to stop taking it safely for at least 14 days before starting the study.
  • You should be able to follow the study rules, which include lifestyle guidelines, using birth control if needed, and keeping a sleep diary.
  • If you have Obstructive Sleep Apnea (OSA) and are being treated for it, you need to use your treatment regularly. OSA is a condition where breathing stops and starts during sleep.
  • You must meet the diagnostic criteria for Narcolepsy Type 2 (NT2) based on specific guidelines. This includes having excessive daytime sleepiness and meeting certain test results.

Who cannot join the trial?

4 criteria

  • Individuals who do not have **Narcolepsy Type 2** cannot participate. Narcolepsy Type 2 is a sleep disorder that causes excessive daytime sleepiness.
  • Participants must be within the specified age range for the study.
  • Both males and females are eligible, but certain health conditions or medications might exclude someone from participating.
  • People who are considered part of a **vulnerable population** may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

ALKS 2680 is a medication being studied for its potential to help people with Narcolepsy Type 2, a condition that causes excessive daytime sleepiness. The trial aims to find out how well this medication works and how safe it is for patients. Participants in the study will receive this medication to see if it can reduce their symptoms of sleepiness during the day.

What is already known about the treatment

ALKS 2680 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating excessive daytime sleepiness associated with Narcolepsy Type 2. It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication is to help manage symptoms of Narcolepsy Type 2, particularly excessive daytime sleepiness. At the molecular level, ALKS 2680 is believed to work by modulating neurotransmitter systems in the brain to promote wakefulness. It is classified pharmacologically as a central nervous system stimulant.

Investigated diseases

Narcolepsy Type 2 – Narcolepsy Type 2 is a sleep disorder characterized by excessive daytime sleepiness. Unlike Narcolepsy Type 1, it does not involve cataplexy, which is sudden muscle weakness. People with this condition often experience overwhelming drowsiness and may fall asleep at inappropriate times. Sleep at night may be disrupted, leading to poor sleep quality. The disorder can affect daily activities and overall quality of life. It is considered a rare disease and requires careful management to address symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515452-20-00Protocol codeALKS 2680-202Estimated enrolment220 patientsSponsorAlkermes Inc.

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