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Study of ALKS 2680 to treat excessive daytime sleepiness in people with idiopathic hypersomnia

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What is this trial about?

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

This clinical trial focuses on Idiopathic Hypersomnia, a sleep disorder characterized by excessive daytime sleepiness without a known cause. The study will test a new medication called ALKS 2680, which is taken as oral tablets, compared to a placebo. The main goal is to evaluate how well ALKS 2680 works in treating excessive daytime sleepiness in people with Idiopathic Hypersomnia.

The study will last 8 weeks and will test different doses of ALKS 2680. During the study, participants will receive either ALKS 2680 tablets or matching placebo tablets. The medication doses being tested range from 10 to 18 milligrams per day. The study is designed as a double-blind trial, which means neither the participants nor the doctors conducting the study will know who receives which treatment.

The effectiveness of the treatment will be measured by tracking changes in sleepiness levels using standardized assessment tools. Throughout the study, participants' health and safety will be closely monitored through various medical checks. The study will also look at how well participants tolerate the medication and any effects it may have on their daily functioning.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and confirmation

    Your diagnosis of Idiopathic Hypersomnia (IH) will be verified based on previous diagnostic tests from the last 10 years

    Your ability to follow study requirements will be assessed, including lifestyle restrictions and keeping sleep records

  2. Step 2

    Baseline measurements

    Your current level of daytime sleepiness will be measured using the Epworth Sleepiness Scale (ESS)

    Your hypersomnia severity will be evaluated using the Idiopathic Hypersomnia Severity Scale (IHSS)

  3. Step 3

    Treatment period

    You will receive either ALKS 2680 tablets or placebo tablets for oral use

    The treatment period will last for 8 weeks

    You will need to take the medication as prescribed and maintain regular sleep records

    If you use sleep apnea treatment, you must continue using it throughout the study

  4. Step 4

    Monitoring and assessments

    Regular health checks will include:

    Laboratory tests to monitor your health

    Vital signs measurements

    Heart monitoring through ECG

    Safety assessments

    Your daytime sleepiness and hypersomnia severity will be evaluated again at week 8

  5. Step 5

    Study completion

    Final evaluations will compare your sleepiness and hypersomnia severity levels to those at the start of the study

    The study will assess how well ALKS 2680 works for treating excessive daytime sleepiness

Who can join the trial?

10 criteria

  • Must be an adult aged 18-65 years old
  • Can be either male or female
  • Must have been diagnosed with Idiopathic Hypersomnia (IH) according to medical guidelines within the past 10 years, confirmed by:
    • PSG (sleep study test that monitors brain activity, breathing and movements during sleep)
    • MSLT (daytime test that measures how quickly you fall asleep)
    • Actigraphy (wrist device that tracks sleep-wake patterns)
    • Must be willing and able to:
      • Follow study requirements and lifestyle restrictions
      • Use appropriate birth control methods
      • Wear an activity tracking device and complete sleep diaries
      • If using OSA (sleep apnea) treatment, must have been using it consistently for 30 days before the study and continue throughout the study
      • Must be able to understand and follow all study procedures and requirements

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Pregnant or breastfeeding women
  • History of substance abuse within the past 2 years
  • Current diagnosis of major depression, anxiety disorder, or other significant psychiatric conditions
  • Severe medical conditions affecting sleep (like sleep apnea - a condition where breathing repeatedly stops and starts during sleep)
  • Use of medications that can affect sleepiness or alertness
  • Night shift workers or people with irregular sleep schedules
  • Body Mass Index (BMI) above 40 (BMI is a measure of body fat based on height and weight)
  • Uncontrolled high blood pressure
  • Significant heart, liver, or kidney disease
  • History of seizures or other neurological disorders
  • Current participation in other clinical trials
  • Unable to maintain a regular sleep schedule
  • History of adverse reactions to similar medications
  • Inability to provide informed consent
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Investigated drugs

ALKS 2680 is an investigational medication being studied for treating excessive daytime sleepiness in people with idiopathic hypersomnia. This is a new drug that aims to help patients who experience persistent daytime drowsiness without a clear underlying cause. The medication is currently known by its development code name as it has not yet been assigned a standard generic name.

What is already known about the treatment

ALKS 2680 - An investigational medication currently in Phase 2 clinical trials for the treatment of Idiopathic Hypersomnia (IH), specifically targeting Excessive Daytime Sleepiness (EDS). While the specific form of administration is still under investigation in clinical trials, this novel compound is being studied as a potential therapeutic option for patients suffering from excessive daytime sleepiness associated with IH, a chronic neurological disorder. The medication is being evaluated through a randomized, double-blind study to determine its optimal dosing range, safety profile, and effectiveness in managing IH symptoms. As this is an experimental drug currently in development, its complete mechanism of action and pharmacological classification are still being established through ongoing research.

Investigated diseases

Idiopathic Hypersomnia - A rare neurological disorder characterized by excessive daytime sleepiness despite normal or prolonged nighttime sleep. People with this condition experience extreme difficulty staying awake during the day and may sleep for unusually long periods, yet still feel unrefreshed. Patients often have significant problems waking up, known as "sleep inertia" or "sleep drunkenness," which can last for several hours. The condition typically begins during adolescence or young adulthood and continues as a chronic disorder. Unlike narcolepsy, this disorder does not involve sudden sleep attacks or muscle weakness, but rather a constant state of sleepiness and mental fog throughout the day.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520981-23-00Protocol codeALKS 2680-203Estimated enrolment126 patientsSponsorAlkermes Inc.

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