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Taking people in United StatesPhase 2

TAK-360 for adults with narcolepsy type 1 with cataplexy

Tests TAK-360 against placebo in adults with narcolepsy type 1.

Key facts

Who runs it
Takeda
Where
Cincinnati, Miami, and Redwood City, United StatesSee the 3 sitesAlso in 6 other countries, 16 sites
Trial code
Registry title
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Status
Recruiting
Phase
Phase 2
People taking part
92 people, planned
Started
4 Jun 2026
Expected to end
28 Nov 2027
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • TAK-360
  • Placebo
Record updated
29 June 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 1 (narcolepsy with cataplexy, sudden muscle weakness while awake). It tests TAK-360 against placebo.

Age
18 Years to 70 Years
Sex
All sexes can join.
Disease stage
A diagnosis of narcolepsy type 1 (NT1) by ICSD-3 or ICSD-3 Text Revision. Body mass index from 18 to 40 kg/m^2.
Earlier treatment
People must stop their existing medicines for NT1 before study treatment starts.

Main reasons for not taking part

  • Another current medical disorder that causes excessive daytime sleepiness.
  • History of heart attack, important heart disease, heart rhythm problems, heart failure or important thyroid disease.
  • History of epilepsy or seizures (except a single fever seizure in childhood), important head injury, or stroke-related problems.
  • Cancer in the past 5 years, with some exceptions.
  • Positive test for hepatitis B, hepatitis C or HIV at screening.

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive)
  • The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1

Who cannot take part

  • The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004
  • The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness
  • The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure
  • The participant has a clinically significant history of head injury or head trauma
  • The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood)
  • The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor)
  • The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening
  • The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds
  • 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, 16 sites

  • Cincinnati, OhioHospital not named in the registryTaking people
  • Miami, FloridaHospital not named in the registryTaking people
  • Redwood City, CaliforniaHospital not named in the registryNot yet recruiting

About the trial

What the trial wants to find out

Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).

Read full original descriptionShow less

The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.

The participants will have to visit the clinic multiple times during this study.

The 5 groups in the trial

  • Part A: TAK-360Treatment being tested

    Participants will receive TAK-360 tablets, orally.

    Treatment: TAK-360

  • Part A: PlaceboPlacebo, for comparison

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

    Treatment: Placebo

  • Part B: TAK-360Treatment being tested

    Participants will receive TAK-360 tablets, orally.

    Treatment: TAK-360

  • Part B: PlaceboPlacebo, for comparison

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

    Treatment: Placebo

  • Part CTreatment being tested

    Participants will receive TAK-360 tablets, orally.

    Treatment: TAK-360

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-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Plain-language title
TAK-360 for adults with narcolepsy type 1 with 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 NCT07633301, who can take part
Record updated
29 June 2026