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Phase 3 Randomized, Double‑Blind, Placebo‑Controlled Study of ALKS 2680 for Excessive Daytime Sleepiness in Adults 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

The study focuses on adults who have Narcolepsy Type 2, a condition that causes sudden and uncontrollable episodes of sleep, especially during the day. The medication being tested is a tablet called ALKS 2680, which will be compared with a matching placebo. The purpose of the study is to evaluate the efficacy and safety of this drug for reducing excessive daytime sleepiness in this population.

Participants will take the study tablets once daily for about 12 weeks and will attend regular clinic visits where they will complete questionnaires and undergo simple tests. One questionnaire, the Epworth Sleepiness Scale, asks about the likelihood of falling asleep in everyday situations to measure daytime sleepiness. Another test, the Maintenance of Wakefulness Test, measures how long a person can stay awake while trying to stay alert. Throughout the study, researchers will monitor how the medication affects sleepiness and overall well‑being, while also checking for any side effects.

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

    Randomization and start of medication

    After enrollment you will be assigned by a computer system to receive either alks 2680 tablets or a matching placebo. the tablet is taken by mouth.

    The tablet contains 00 mg of the study drug. the exact schedule for taking the tablet (for example, once each day) is provided in the study instructions and must be followed for the entire 12‑week treatment period.

  2. Step 2

    Baseline assessments

    At the first visit (week 0) you will complete the epworth sleepiness scale, a questionnaire that measures how sleepy you feel during daily activities.

    You will also undergo the maintenance of wakefulness test, a short test that measures how long you can stay awake when asked to do so.

  3. Step 3

    Ongoing medication period

    You will continue to take the assigned tablet every day for a total of 12 weeks.

    During this period you may be asked to keep a simple diary of any side effects or missed doses and to bring the medication bottles to each scheduled visit.

  4. Step 4

    Interim assessments

    At week 4 and week 8 you will return to the study site for follow‑up visits.

    At each visit you will repeat the epworth sleepiness scale and may complete other questionnaires that ask about your daily functioning and quality of life.

  5. Step 5

    Final assessments and study completion

    At week 12 you will attend the final study visit.

    You will again complete the epworth sleepiness scale, repeat the maintenance of wakefulness test, and answer the same patient‑reported outcome questionnaires used earlier.

    After the final assessments the study medication will be discontinued and you will be instructed on any further follow‑up that may be needed.

Who can join the trial?

7 criteria

  • Be between 18 and 70 years old when you sign the consent form.
  • Be able and willing to sign a written informed consent form, which means you understand the study and agree to take part.
  • Have a body mass index (BMI) of 18 to 40 kg/m2 at the first study visit (BMI is a number that relates your weight to your height).
  • In the doctor’s view, you are not getting enough relief or are having side effects from the medicines you currently take for narcolepsy, and you can stop those medicines safely for the time needed in the study (this stopping period is called a washout period).
  • Be willing and able to follow the study’s rules, including any lifestyle changes and using birth‑control methods if needed (contraception guidance).
  • Be willing and able to wear a small activity monitor (actigraphy) and keep a daily record of your sleep (sleep diary) during the screening phase.
  • If you are being treated for obstructive sleep apnea (OSA), you must have used your 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

  • Having uncontrolled sleep breathing problems (such as sleep apnea) that are measured as an apnea‑hypopnea index of 15 or more events per hour, or if you are already treated for sleep apnea, an average index of 10 or more events per hour in the past month, or a central apnea index greater than 5 per hour.
  • Showing abnormal results on any lab tests taken at the first study visit.
  • Currently taking, or having taken in the last six months, any antidepressant medications.
  • Being pregnant, breastfeeding, or planning to become pregnant while the study is being conducted.
  • Being enrolled in another research study that involves a new treatment, or having received any experimental drug or device within 30 days before the first visit, including previous participation in Study ALKS 2680‑202.
  • Working for Alkermes, the contract research organization, the study site, or being an immediate family member (spouse, parent, sibling, or child) of someone who works for these groups.
  • Having another sleep disorder or condition that could affect your normal sleep‑wake cycle, as listed in the study details.
  • Having a serious heart (cardiovascular) disease during screening or within the two years before the first visit.
  • Having a major psychiatric disorder (such as severe depression, bipolar disorder, etc.) or a substance use disorder (dependence on alcohol or drugs) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
  • Having a history or current serious illness, disease, abnormal condition, or surgery that could affect safety or study results, including neurological problems like dementia, neurodegenerative diseases, stroke, or seizures (except isolated childhood fever seizures).
  • Having a current or recent (within six months) gastrointestinal problem that could affect how the medication is absorbed, such as a history of poor nutrient absorption or stomach surgery like a Roux‑en‑Y gastric bypass.
  • Having had any type of cancer (treated or untreated) in the past five years, except for certain skin cancers (carcinoma in situ or basal cell) that were fully resolved and approved by the study sponsor.
  • Having a known risk for, or a history of, narrow‑angle glaucoma, an eye condition where the drainage angle is too small.
  • Testing positive for alcohol on a breath test or showing illegal drugs on a urine test at the fourth study visit.
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Investigated drugs

ALKS 2680 is an experimental oral tablet being tested as a possible treatment for excessive daytime sleepiness in adults with narcolepsy type 2. In this study, participants take the tablet each day, and researchers compare how they feel and how much they sleep during the day to see if the medicine improves alertness and reduces sleep attacks. The drug is still under investigation, so its safety and how well it works are being closely monitored during the trial.

What is already known about the treatment

ALKS 2680 - ALKS 2680 is taken as an oral tablet that patients swallow with water. It is still an experimental drug currently in Phase 3 clinical trials and has not yet been approved for general medical use. The medication is being studied to treat excessive daytime sleepiness in adults with narcolepsy type 2. It is thought to work by influencing brain chemicals that control wakefulness, and it is classified as a central nervous system stimulant.

Investigated diseases

Narcolepsy type 2 - Narcolepsy type 2 is a sleep disorder characterized by excessive daytime sleepiness without cataplexy. It usually begins in adolescence or early adulthood. People experience sudden urges to sleep during the day and may have fragmented nighttime sleep. The condition often worsens over time, leading to longer sleep episodes and difficulty staying awake. Some individuals also have sleep paralysis or vivid dreams when falling asleep. The symptoms tend to be stable but can become more noticeable with stress or irregular sleep schedules.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523912-35-00Protocol codeALKS 2680-303Estimated enrolment174 patientsSponsorAlkermes Inc.

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