Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Long‑term Safety and Tolerability Study of TAK‑360 in Adults with Narcolepsy or Idiopathic Hypersomnia

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study looks at adults who have central hypersomnia conditions, specifically Narcolepsy or Idiopathic Hypersomnia, which cause overwhelming daytime sleepiness. Participants will receive the oral tablet called TAK-360 or a placebo. The purpose of the study is to evaluate the long‑term safety and tolerability of the drug.

During the trial, participants will take the assigned tablet each day for up to several years and attend regular clinic visits. At each visit doctors will ask about side effects and will perform simple sleep assessments, such as the ESS questionnaire that rates how sleepy a person feels, the MWT that measures how long a person can stay awake, the IHSS questionnaire for idiopathic hypersomnia symptoms, the NSS-CT or NSS-2-CT questionnaires for narcolepsy symptoms, and participants will record cataplexy episodes using a WCR diary. The study will monitor any new health problems and changes in sleepiness over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study you will complete the Epworth Sleepiness Scale (ESS), a questionnaire that measures daytime sleepiness.

    If you have idiopathic hypersomnia you will also fill out the Idiopathic Hypersomnia Symptom Scale (IHSS).

    If you have narcolepsy you will complete the Narcolepsy Symptom Scale – Cataplexy (NSS‑CT) for type 1 or the NSS‑2‑CT for type 2.

    A sleep test called the Multiple Sleep Latency Test (MWT) will be performed to measure how quickly you fall asleep during the day.

  2. Step 2

    Start Taking Study Medication

    You will receive either TAK‑360 tablets or a matching placebo tablet that looks the same but contains no active substance.

    Each tablet is a film‑coated tablet taken by mouth once daily.

    The dose specified in the protocol is 0 mg per tablet; you will follow the dosing schedule for the entire study period.

  3. Step 3

    Monthly Safety and Symptom Checks (Months 1‑4)

    Every month for the first four months you will attend a visit (in person or remotely) to report any side effects or new health problems.

    You will complete the ESS questionnaire each month to track changes in daytime sleepiness.

  4. Step 4

    Quarterly Assessments (Month 6, 9, 12, then every 3 months)

    At month 6, month 9, month 12 and every three months thereafter you will repeat the ESS questionnaire.

    If you have idiopathic hypersomnia you will also complete the IHSS at these visits.

    If you have narcolepsy type 1 you will repeat the NSS‑CT, and if you have type 2 you will repeat the NSS‑2‑CT.

  5. Step 5

    Specific Tests at 3 and 6 Months

    At month 3 and month 6 you will undergo the MWT again to measure any change in sleep latency.

    If you have narcolepsy type 1 you will record cataplexy episodes in a patient‑reported eDiary at month 3, 6, 9, 12, 18 and 24.

  6. Step 6

    Long‑Term Follow‑Up

    You will continue taking the study tablet daily for the duration of the trial, which may extend up to several years.

    You may report adverse events at any time, and periodic safety visits will continue as described above.

    All assessments will follow the schedule outlined in the previous steps to evaluate the long‑term safety and tolerability of TAK‑360.

Who can join the trial?

4 criteria

  • Confirmed diagnosis of one of the following sleep disorders: narcolepsy with cataplexy (NT1) (a condition that causes sudden sleep attacks and brief loss of muscle control triggered by strong emotions), narcolepsy without cataplexy (NT2) (similar sleep attacks but without the loss of muscle control), or idiopathic hypersomnia (IH) (long‑lasting excessive sleepiness that is not caused by another known condition).
  • Must have finished the treatment portion of an earlier study using the medicine TAK‑360.
  • Both men and women are eligible to take part.
  • Must be in the age group allowed by the study, which includes children and adolescents (the trial lists age codes “3” and “4”).

Who cannot join the trial?

2 criteria

  • You cannot take part if you have a known allergy called hypersensitivity to any part (component) of the study drug TAK‑360 or to medicines that are similar (related compounds).
  • You cannot take part if a pregnancy test shows you are pregnant at the start of the study, or if you are currently feeding a baby with breast milk (breastfeeding).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

TAK-360 is an experimental oral tablet that is being studied to see how safe and well‑tolerated it is when taken for a long time by people who have certain types of central hypersomnia (a condition that makes it hard to stay awake). In this trial participants will swallow the film‑coated tablets, and researchers will monitor them for any side effects, how they feel, and whether the medicine can be used safely over many months. The goal is to learn whether TAK‑360 can be a helpful treatment option for this sleep disorder.

What is already known about the treatment

  • TAK-360

    TAK-360 is taken by mouth as a film‑coated tablet, meaning the patient swallows the pill whole. It is still an investigational drug and has not received marketing approval, so it appears only in early clinical studies and scientific reports. The tablet is being tested for people with central hypersomnia, a condition that causes excessive daytime sleepiness. It works by a small‑molecule action that influences brain chemicals that control wakefulness, placing it in the class of novel central nervous system wake‑promoting agents.

  • TAK-360 placebo

    The placebo is also a film‑coated tablet taken orally, but it contains no active medicine, only the inactive ingredients that make up the pill. It is used solely as a control in the trial and is not a marketed drug. Because it has no therapeutic effect, it serves only to help researchers compare the safety and tolerability of the real drug against a neutral tablet. It belongs to the category of inert control substances used in clinical research.

Investigated diseases

  • Idiopathic hypersomnia

    Chronic condition causing excessive daytime sleepiness despite normal or long night sleep. People feel a strong need to nap and have difficulty waking. Over time, sleepiness may become more persistent and affect daily activities. Cognitive slowing and feeling of grogginess after sleep can increase. Symptoms often remain stable but can fluctuate.

  • Narcolepsy type 1

    Neurological disorder marked by excessive daytime sleepiness and cataplexy (sudden loss of muscle tone). It usually begins in adolescence or early adulthood. The condition may progress to more frequent sleep attacks and stronger cataplexy episodes. Nighttime sleep can become fragmented with vivid dreams. Symptoms tend to persist and may become more disabling over years.

  • Narcolepsy type 2

    Similar to type 1 but without cataplexy. It also features excessive daytime sleepiness and disrupted nighttime sleep. The disorder often starts in young adulthood and may gradually worsen, leading to more frequent sleep attacks. Cognitive performance and mood can be affected as the disease progresses. Symptoms are generally stable but can increase in severity over time.

Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522833-68-01Protocol codeTAK-360-2003Estimated enrolment130 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.