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Taking people in United StatesPhase 2

TAK-360 for adults with narcolepsy type 2, without cataplexy

Tests TAK-360 against placebo in adults with narcolepsy type 2.

Key facts

Who runs it
Takeda
Where
Atlanta, Auburn, Austin, Bowie, Bradenton, Brandon, Chandler, Chula Vista, Cincinnati, Cleveland, Colorado Springs, Columbia, Dallas, Denver, El Paso, Huntersville, Jacksonville, Lansing, Lathrup Village, Mansfield, Miami, Middletown, Norfolk, Orlando, Redwood City, San Antonio, Santa Ana, St Louis, and Winston-Salem, United StatesSee the 31 sitesAlso in 6 other countries, 20 sites
Registry title
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Status
Recruiting
Phase
Phase 2
People taking part
88 people, planned
Started
6 May 2025
Expected to end
30 Nov 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • TAK-360
  • Placebo
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with narcolepsy type 2 (narcolepsy without cataplexy). It tests TAK-360 tablets against a placebo for 4 weeks.

Age
18 Years to 70 Years
Sex
All sexes
Disease stage
A documented, current diagnosis of narcolepsy type 2 (NT2). Body weight ≥40 kg (88 lb) and BMI between 16 and 38 kg/m^2.

Main reasons for not taking part

  • Another current medical disorder causing heavy daytime sleepiness
  • Cancer in the past 5 years, except some treated, stable in-situ cancers after approval
  • Positive test for hepatitis B, hepatitis C or HIV
  • Epilepsy, seizures or convulsions, or a significant head injury
  • Medically significant thyroid disease, or past stroke-type brain problems such as cerebral ischemia or aneurysm

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) [inclusive]
  • The participant has a documented, current diagnosis of NT2

Who cannot take part

  • The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2
  • The participant has medically significant thyroid disease
  • The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor)
  • The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening)
  • The participant has a clinically significant history of head injury or head trauma
  • The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood)
  • The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in United States

Also in 6 other countries, 20 sites

  • Atlanta, GeorgiaHospital not named in the registryTaking people
  • Auburn, AlabamaHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryTaking people
  • Bowie, MarylandHospital not named in the registryTaking people
  • Bradenton, FloridaHospital not named in the registryTaking people
  • Brandon, FloridaHospital not named in the registryTaking people
  • Chandler, ArizonaHospital not named in the registryNo longer taking part
  • Chula Vista, CaliforniaHospital not named in the registryTaking people
  • Cincinnati, OhioHospital not named in the registryTaking people
  • Cleveland, OhioHospital not named in the registryTaking people
  • Colorado Springs, ColoradoHospital not named in the registryTaking people
  • Columbia, South CarolinaHospital not named in the registryTaking people
  • Dallas, TexasHospital not named in the registryNo longer taking part
  • Denver, North CarolinaHospital not named in the registryTaking people
  • El Paso, TexasHospital not named in the registryNo longer taking part
  • Huntersville, North CarolinaHospital not named in the registryTaking people
  • Jacksonville, FloridaHospital not named in the registryTaking people
  • Lansing, MichiganHospital not named in the registryTaking people
  • Lathrup Village, MichiganHospital not named in the registryTaking people
  • Mansfield, TexasHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryTaking people
  • Miami, FloridaHospital not named in the registryTaking people
  • Middletown, New JerseyHospital not named in the registryTaking people
  • Norfolk, VirginiaHospital not named in the registryTaking people
  • Orlando, FloridaHospital not named in the registryTaking people
  • Orlando, FloridaHospital not named in the registryNo longer taking part
  • Redwood City, CaliforniaHospital not named in the registryTaking people
  • San Antonio, TexasHospital not named in the registryTaking people
  • Santa Ana, CaliforniaHospital not named in the registryTaking people
  • St Louis, MissouriHospital not named in the registryTaking people
  • Winston-Salem, North CarolinaHospital not named in the registryTaking people

About the trial

What the trial wants to find out

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

Read full original descriptionShow less

The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

The 2 groups in the trial

  • TAK-360Treatment being tested

    Participants will receive TAK-360 tablets, orally, for 4 weeks.

  • PlaceboPlacebo, for comparison

    Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
Plain-language title
TAK-360 for adults with narcolepsy type 2, without cataplexyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06952699, who can take part
Record updated
8 October 2026