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Efficacy and Safety of ALKS 2680 and Alixorexton in Adults with Narcolepsy Type 1

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What is this trial about?

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

Narcolepsy Type 1 is a rare sleep disorder that causes strong urges to fall asleep during the day and sudden loss of muscle tone called cataplexy. The condition often leads to feeling very tired and having difficulty staying awake, a problem known as excessive daytime sleepiness. The study will test an oral tablet called ALKS 2680, which is being evaluated as a possible treatment for these symptoms.

The purpose of the study is to determine whether ALKS 2680 can reduce daytime sleepiness in adults with Narcolepsy Type 1. Participants will be randomly assigned to receive either the study drug or a placebo for about twelve weeks. During the study, they will complete a questionnaire called the Epworth Sleepiness Scale that asks how likely they are to fall asleep in everyday situations, and they will take a short test called the Maintenance of Wakefulness Test that measures how long they can stay awake when asked to do so. Their episodes of cataplexy will also be recorded each week.

Throughout the trial, researchers will monitor participants for any side effects and will collect the questionnaire and test results to evaluate the safety and effectiveness of the medication. The collected information will help decide if the drug provides a beneficial option for managing the symptoms of this sleep disorder.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    After joining the study, you will attend a baseline visit where the research team will confirm the diagnosis of narcolepsy type 1 and collect information about your sleep patterns, daytime sleepiness, and any cataplexy episodes.

    You will complete questionnaires such as the Epworth Sleepiness Scale and undergo safety tests, including blood work and a brief sleep assessment.

  2. Step 2

    Randomization and medication assignment

    Based on a random process, you will be assigned to receive either the study drug alks 2680 or a matching placebo. the assignment is double‑blind, meaning neither you nor the study staff will know which one you receive.

  3. Step 3

    Start of study medication

    You will begin taking one oral tablet each day. each tablet contains 00 mg of the assigned product (either alks 2680 or the placebo). the tablet should be swallowed with water at the same time each day for a total of 12 weeks.

  4. Step 4

    Daily symptom diary

    Each day you will record your level of daytime sleepiness, any cataplexy episodes, and any side effects you notice. this information helps the study assess how the medication affects your symptoms.

  5. Step 5

    Clinic visit at week 4

    Four weeks after starting the medication you will return to the clinic for a safety check. the staff will review your diary, measure vital signs, and may repeat blood tests to monitor your health.

  6. Step 6

    Clinic visit at week 8

    At eight weeks you will have another clinic visit. you will complete the Epworth Sleepiness Scale again and may undergo the Maintenance of Wakefulness Test, which measures how long you can stay awake in a quiet setting.

  7. Step 7

    Final visit at week 12

    After 12 weeks of daily dosing you will attend the final study visit. you will repeat all questionnaires, including the Epworth Sleepiness Scale and the cataplexy frequency log, and you may have the final safety laboratory tests.

    Any remaining study tablets will be returned, and the study medication will be stopped.

Who can join the trial?

7 criteria

  • Be between 18 and 70 years old when you give your consent to join the study.
  • Be willing and able to sign an informed consent form, which explains the study and your rights, as required by local regulations.
  • Have a body mass index (BMI) of at least 18 and no more than 40 kg/m² at the first visit. (BMI is a calculation that uses your weight and height to estimate body size.)
  • According to the doctor, you should be having an unsatisfactory response (meaning the medicines are not working well enough) or side effects from any drugs used for narcolepsy symptoms, and you must be able to stop those medicines safely for the time needed by the study (called a washout period).
  • Be able to understand and follow the study rules, including any lifestyle restrictions and using birth‑control methods if the doctor thinks it is needed.
  • Be able to follow the requirements for actigraphy (a small device that records movement to track sleep), a cataplexy diary (a notebook where you record episodes of sudden muscle weakness), and a sleep diary (a record of your sleep patterns) during the screening phase.
  • If you receive treatment for obstructive sleep apnea (OSA) (a condition where breathing stops briefly during sleep), you must have used your usual OSA therapy consistently for the 30 days before the first visit and continue using it throughout the study, as confirmed by the doctor.

Who cannot join the trial?

14 criteria

  • If you have serious breathing problems during sleep that are not well controlled—such as frequent pauses in breathing (called apnea) that occur 15 or more times per hour, or if you are being treated for obstructive sleep apnea but still have an average of 10 or more pauses per hour, or if you have a type of breathing stop called central apnea that happens more than 5 times per hour—you cannot join the study.
  • If your blood tests or other laboratory results are abnormal in ways the study specifies at the first visit, you cannot join the study.
  • If you are currently taking or have taken antidepressant medicines for any reason other than controlling cataplexy (sudden loss of muscle tone) within the past six months, you cannot join the study.
  • If you are pregnant, breastfeeding, or planning to become pregnant during the study, you cannot join the study.
  • If you are already participating in another study that tests a treatment (an interventional clinical trial) or have taken any experimental drug or used an experimental device within 30 days before the first visit, or if you have previously taken part in this same study, you cannot join the study.
  • If you work for the drug company, the research organization, or the study site, or if you are an immediate family member (spouse, parent, sibling, or child) of someone who works for them, you cannot join the study.
  • If you have another sleep disorder that could affect your normal sleep‑wake cycle, you cannot join the study.
  • If you have a serious heart or blood‑vessel condition (significant cardiovascular disease) now or within the two years before the first visit, you cannot join the study.
  • If you have a major mental health condition or a problem with drug or alcohol use, as defined by the standard diagnostic guide (DSM‑5), you cannot join the study.
  • If you have another serious illness, disease, abnormal condition, or have had major surgery that might affect your safety or ability to complete the study—such as brain disorders like dementia, neurodegenerative diseases, stroke, or seizures (except isolated childhood fever seizures)—you cannot join the study.
  • If you have a current or recent (within the past six months) stomach or intestinal problem that could affect how the study drug is absorbed, such as a history of malabsorption or stomach surgery like Roux‑en‑Y gastric bypass, you cannot join the study.
  • If you have had cancer (treated or untreated) in the past five years, you cannot join the study, unless it was a very early skin cancer (carcinoma in situ) or a basal cell skin cancer that was fully treated and cleared.
  • If you have a known risk for, or a history of, narrow‑angle glaucoma (an eye condition that can increase pressure inside the eye), you cannot join the study.
  • If you test positive for alcohol on a breath test or for illegal drugs on a urine drug screen at the final visit, you cannot join the study.
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Investigated drugs

ALKS 2680 is an experimental oral tablet being studied as a possible treatment for adults with Narcolepsy Type 1. In the trial, participants take this tablet by mouth, and researchers are looking to see if it can lessen the excessive daytime sleepiness that is a key symptom of narcolepsy. The medication is still under investigation, so its safety and how well it works are being carefully evaluated during the study.

What is already known about the treatment

ALKS 2680 - This medication is taken as an oral tablet that you swallow with water. It is currently an investigational drug, meaning it is still being studied and has not yet received market approval. The tablet is being tested to help adults with Narcolepsy Type 1 who experience excessive daytime sleepiness. It works by activating the brain’s orexin receptors, which promote wakefulness, and it is classified as an orexin‑receptor agonist.

Investigated diseases

Narcolepsy type 1 - It is a chronic neurological disorder marked by overwhelming daytime sleepiness and sudden loss of muscle tone triggered by strong emotions. The condition typically begins in childhood or adolescence and continues over time. Sleepiness episodes can happen many times a day, and cataplexy attacks may become more frequent. Nighttime sleep is often disrupted, which can worsen the daytime symptoms. The intensity of symptoms may vary, but they usually remain present.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524711-36-00Protocol codeALKS 2680-304Estimated enrolment138 patientsSponsorAlkermes Inc.

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