Recruiting
Phase 2

TAK-360

Sponsor:

Takeda

Code:

NCT06952699

Conditions

Narcolepsy Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TAK-360

Placebo

Study Details

Brief summary:

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

Study ID

NCT06952699

Start date

May 6, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Key Inclusion 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.

Key Exclusion Criteria:

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-360

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

placebo comparator: Placebo

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

Interventions

TAK-360

TAK-360 tablet.

Placebo

TAK-360 matching placebo tablet.

Primary outcome measure

  • Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 15 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Takeda Site 36

Recruiting

Auburn, Alabama, United States, 36832

Takeda Site 40

Recruiting

Chula Vista, California, United States, 91910

Takeda Site 14

Recruiting

Redwood City, California, United States, 94063-3132

Takeda Site 10

Recruiting

Santa Ana, California, United States, 92705-8519

Takeda Site 1

Recruiting

Colorado Springs, Colorado, United States, 80918-3408

Takeda Site 48

Recruiting

Bradenton, Florida, United States, 34209

Takeda Site 13

Recruiting

Brandon, Florida, United States, 33511-5719

Takeda Site 46

Recruiting

Jacksonville, Florida, United States, 32209

Takeda Site 44

Recruiting

Miami, Florida, United States, 33155

Takeda Site 35

Recruiting

Miami, Florida, United States, 33176

Takeda Site 3

Recruiting

Orlando, Florida, United States, 32803-1468

Takeda Site 33

Recruiting

Orlando, Florida, United States, 32807

Takeda Site 32

Recruiting

Atlanta, Georgia, United States, 30328

Takeda Site 49

Recruiting

Bowie, Maryland, United States, 20715

Takeda Site 50

Recruiting

Lansing, Michigan, United States, 48911

Takeda Site 34

Recruiting

Lathrup Village, Michigan, United States, 48076

Takeda Site 4

Recruiting

St Louis, Missouri, United States, 63123-6968

Takeda Site 37

Recruiting

Middletown, New Jersey, United States, 07748

Takeda Site 8

Recruiting

Denver, North Carolina, United States, 28037

Takeda Site 6

Recruiting

Huntersville, North Carolina, United States, 28078-5082

Takeda Site 41

Recruiting

Winston-Salem, North Carolina, United States, 27103

Takeda Site 5

Recruiting

Cincinnati, Ohio, United States, 45245-4500

Takeda Site 45

Recruiting

Cleveland, Ohio, United States, 44106

Takeda Site 2

Recruiting

Columbia, South Carolina, United States, 29201-2923

Takeda Site 38

Recruiting

Austin, Texas, United States, 78731

Takeda Site 42

Recruiting

El Paso, Texas, United States, 79912

Takeda Site 7

Recruiting

San Antonio, Texas, United States, 78229-4849

Takeda Site 11

Recruiting

Norfolk, Virginia, United States, 23510-1021

More Information

Sponsor

Takeda

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Narcolepsy without Cataplexy
  • NT2
  • TAK-360

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-08-20.