A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Description

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. 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.

Conditions

Narcolepsy Type 2

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Study Overview

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Study Details

Study overview

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. 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.

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)

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Condition
Narcolepsy Type 2
Intervention / Treatment

-

Contacts and Locations

Redwood City

Takeda Site 14, Redwood City, California, United States, 94063-3132

Santa Ana

Takeda Site 10, Santa Ana, California, United States, 92705-8519

Colorado Springs

Takeda Site 1, Colorado Springs, Colorado, United States, 80918-3408

Brandon

Takeda Site 13, Brandon, Florida, United States, 33511-5719

Orlando

Takeda Site 3, Orlando, Florida, United States, 32803-1468

Saint Louis

Takeda Site 4, Saint Louis, Missouri, United States, 63123-6968

Denver

Takeda Site 8, Denver, North Carolina, United States, 28037

Huntersville

Takeda Site 6, Huntersville, North Carolina, United States, 28078-5082

Cincinnati

Takeda Site 5, Cincinnati, Ohio, United States, 45245-4500

Columbia

Takeda Site 2, Columbia, South Carolina, United States, 29201-2923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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) \[inclusive\].
  • 2. The participant has a documented, current diagnosis of NT2.
  • 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
  • 2. The participant has medically significant thyroid disease.
  • 3. 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).
  • 4. 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).
  • 5. The participant has a clinically significant history of head injury or head trauma.
  • 6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
  • 7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2026-04-23