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A Randomized Double‑Blind Placebo‑Controlled Study of TAK‑360 in Adults with Narcolepsy with Cataplexy (Type 1)

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What is this trial about?

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

The condition being studied is Narcolepsy with Cataplexy, a rare sleep disorder that causes overwhelming daytime sleepiness and sudden loss of muscle tone triggered by strong emotions. The investigational medication being tested is TAK-360, an oral tablet designed to reduce these symptoms, and it will be compared with a matching placebo that contains no active drug.

The purpose of the study is to evaluate the safety and tolerability of the drug, meaning how well participants can use it without harmful side effects. Participants will be assigned by chance to receive either the study drug or the placebo, and neither the participants nor the study staff will know which treatment is given (a double‑blind design). The trial will last several weeks, during which participants will take one tablet each day and attend regular visits for health checks and questionnaires about sleepiness and cataplexy.

Throughout the study, researchers will monitor any side effects and record changes in daytime sleepiness and the frequency of cataplexy episodes. The information collected will help determine whether the medication is safe enough to move forward in development for people with this 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

    Enrollment and baseline assessments

    After you join the study, you sign an informed consent form.

    You undergo baseline assessments that may include a medical history review, physical examination, and sleep tests to document your condition.

  2. Step 2

    Randomization

    You are randomly assigned to receive either tak-360 (the test drug) or tak-360 placebo (an inactive tablet).

    The assignment is double‑blind, meaning neither you nor the study staff know which product you receive.

  3. Step 3

    Receiving study medication

    You receive oral film‑coated tablets.

    The tablet contains a dose of 0 mg of the active substance, as specified in the trial documentation.

    The tablets are taken by mouth; the exact schedule (such as once daily) is provided by the study staff.

  4. Step 4

    Medication period

    You take the study tablets according to the instructions for the entire treatment period.

    You keep a diary of each dose taken and note any symptoms that arise.

  5. Step 5

    Week 6 clinic visit

    At week 6 you attend a scheduled clinic visit.

    During this visit the following assessments are performed:

    multiple sleep latency test – a test that measures how quickly you fall asleep in a quiet environment.

    epworth sleepiness scale – a questionnaire that asks about your level of daytime sleepiness.

    Additional safety checks are made to record any adverse events (new or worsening symptoms).

  6. Step 6

    Ongoing safety monitoring

    Throughout the trial you are asked to report any side effects or new health problems to the study team.

    The study team may contact you for additional safety evaluations if needed.

  7. Step 7

    End of treatment and final assessment

    At the end of the study you stop taking the study tablets.

    A final assessment is performed to evaluate safety, tolerability, and any changes in sleep measures.

Who can join the trial?

9 criteria

  • The participant must be willing and able to understand the study and follow all study procedures, as judged by the doctor.
  • The participant must sign a written consent form (called an informed consent) and give any required privacy permission before any study activities start.
  • The participant must be between 18 and 70 years old when they sign the consent form.
  • The participant’s body mass index (BMI) must be between 18 and 40 kilograms per square meter (kg/m²). BMI is a measure that uses height and weight to estimate body size.
  • The participant must have a confirmed diagnosis of narcolepsy type 1 (narcolepsy with cataplexy) according to the International Classification of Sleep Disorders, Third Edition (ICSD‑3) and supported by test results.
  • The participant must test positive for either the HLA‑DQB1*06:02 genetic marker (either one or two copies) or have a low level of hypocretin‑1 in the spinal fluid (≤110 pg/mL, which is less than one‑third of normal). HLA is a gene that helps the immune system, and hypocretin‑1 is a chemical in the brain that controls wakefulness.
  • The participant must be judged by the doctor to be healthy enough for the study, based on lab safety tests, medical history, a physical exam, a 12‑lead electrocardiogram (ECG) (a test that records the heart’s electrical activity), and vital sign measurements taken at screening and before the first dose.
  • The participant must agree to use birth control methods as required by the study (the contraceptive requirements).
  • Depending on the country’s rules, the participant may need to be part of a Social Security scheme or be a beneficiary of one.

Who cannot join the trial?

22 criteria

  • The participant has another medical condition that causes excessive daytime sleepiness, besides narcolepsy with cataplexy.
  • The participant has had a heart attack (also called myocardial infarction) or has heart problems such as thyroid disease, coronary artery disease, abnormal heart rhythm, or heart failure, or any ongoing condition that the doctor thinks makes participation unsafe.
  • The participant has a current or recent (within 6 months) stomach or intestinal problem that could affect how the medicine is absorbed.
  • The participant has had cancer in the past 5 years, except for certain skin cancers (carcinoma in situ, basal cell carcinoma) that have been fully treated and approved by the medical monitor.
  • The participant has a significant history of head injury or head trauma.
  • The participant has a history of epilepsy, seizures, or convulsions, except for a single fever-related seizure in childhood.
  • The participant has a history of a small stroke (cerebral ischemia), a brief “mini‑stroke” called a transient ischemic attack within the last 5 years, an intracranial aneurysm (a bulge in a brain blood vessel), or an arteriovenous malformation (abnormal blood vessel connection in the brain).
  • The participant has serious multiple or severe allergies (such as to food, medication, or latex) or has ever had an anaphylactic reaction (a severe, life‑threatening allergic response) or strong intolerance to medicines or foods that the doctor feels makes trial participation risky.
  • The participant is known to be allergic (hypersensitive) to any part of the TAK‑360 medication or related substances.
  • The participant cannot avoid, or expects to use, foods that are not allowed in the study.
  • The participant has taken part in another experimental drug study and is still within the required waiting period after the last dose of that drug.
  • The participant plans to join another active interventional trial while taking part in this study, or has already taken part in another part of the TAK‑360 study.
  • The participant has ever stopped an orexin receptor 2 agonist (a type of drug that includes TAK‑360) because of safety or tolerability problems.
  • The participant tests positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibody/antigen at screening.
  • The participant has a positive pregnancy test at screening or on Day ‑2, or is currently breastfeeding.
  • The participant has a positive urine test for illegal drugs or a positive alcohol test at screening or on Day ‑2 (except for prescribed stimulant medications; some cannabidiol products may be allowed at the investigator’s discretion).
  • The participant works at the trial site or is an immediate family member (spouse, parent, child, sibling) of a trial site employee who is involved in running the study, which could create a conflict of interest.
  • The participant drinks excessive amounts of caffeine.
  • The participant drinks excessive amounts of alcohol.
  • The participant usually goes to bed after 1:00 AM, works night or rotating shifts, has traveled with significant jet lag, or plans to travel with significant jet lag within the next 6 months.
  • The investigator believes the participant is unlikely to follow the study rules or is otherwise unsuitable for the trial.
  • The participant is considered a vulnerable person under local laws (for example, someone under legal guardianship, detained, receiving psychiatric care without consent, or otherwise unable to give informed consent).
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Investigated drugs

TAK-360 is an oral, film‑coated tablet that is being tested as a new treatment for narcolepsy with cataplexy (also called Narcolepsy Type 1). In this study, participants take the tablet to see if it can safely reduce the daytime sleepiness and sudden loss of muscle tone that characterize this condition. Researchers are closely monitoring how well the drug is tolerated and whether any side effects occur, with the goal of determining if TAK‑360 could become a useful option for people living with narcolepsy.

What is already known about the treatment

  • TAK-360

    TAK-360 is taken as a film‑coated tablet that is swallowed whole. It is an experimental drug that is still being studied and has not yet received marketing approval. The tablet is being tested to help people with narcolepsy with cataplexy, a condition that causes sudden daytime sleep attacks and muscle weakness. It works by affecting brain chemicals that control the sleep‑wake cycle and is classified as an investigational wake‑promoting agent for the nervous system.

  • TAK-360 placebo

    The placebo looks the same as the active tablet but contains no medicine, only the inactive ingredients used to make the tablet. It is used in the study to show how the real drug compares to taking nothing active. The placebo has no therapeutic effect and serves only as a control for safety and effectiveness measurements.

Investigated diseases

Narcolepsy type 1 - Narcolepsy type 1 is a chronic neurological condition that causes overwhelming daytime sleepiness and sudden loss of muscle tone called cataplexy, often triggered by strong emotions. The disorder usually begins in childhood or adolescence and the frequency of sleep attacks and cataplexy episodes can increase over time. As the condition progresses, individuals may experience fragmented nighttime sleep and vivid dreaming while awake. The symptoms tend to persist and may become more noticeable with stress or irregular sleep patterns.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522587-33-00Protocol codeTAK-360-2004Estimated enrolment92 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

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