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

Last updated: May 15, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2

Condition

Narcolepsy

Cataplexy

Treatment

TAK-360

Placebo

Clinical Study ID

NCT06952699
TAK-360-2001
2024-517711-70-00
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a bodymass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].

  2. The participant has a documented, current diagnosis of NT2.

Exclusion

Key Exclusion Criteria:

  1. The participant has a current medical disorder associated with excessive daytimesleepiness (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 doesnot apply to participants with carcinoma in situ [such as basal cell carcinoma] thathas 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 testresult: 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 asingle febrile seizure in childhood).

  7. The participant has a history of cerebral ischemia, transient ischemic attack (<5years from screening), intracranial aneurysm, or arteriovenous malformation.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: TAK-360
Phase: 2
Study Start date:
May 06, 2025
Estimated Completion Date:
April 23, 2026

Connect with a study center

  • Takeda Site 28

    Beijing, Beijing 100053
    China

    Site Not Available

  • Takeda Site 29

    Guangzhou, Guangzhou 510515
    China

    Site Not Available

  • Takeda Site 27

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Takeda Site 17

    Montpellier, 34090
    France

    Site Not Available

  • Takeda Site 15

    Paris, 75013
    France

    Site Not Available

  • Takeda Site 25

    New Territories, 999077
    Hong Kong

    Site Not Available

  • Takeda Site 22

    Roma, Lazio 133
    Italy

    Site Not Available

  • Takeda Site 23

    Bellaria, Verona 40139
    Italy

    Site Not Available

  • Takeda Site 24

    Yokohama, Kanagawa 222-0033
    Japan

    Site Not Available

  • Takeda Site 9

    Kumamoto-shi, Kumamoto 862-0954
    Japan

    Site Not Available

  • Takeda Site 30

    Urasoe, Okinawa 901-2132
    Japan

    Site Not Available

  • Takeda Site 20

    Bunkyo-ku, Tokyo 112-0012
    Japan

    Site Not Available

  • Takeda Site 26

    Sumida-Ku, Tokyo 130-0004
    Japan

    Site Not Available

  • Takeda Site 12

    Osaka-Shi, Ôsaka 532-0003
    Japan

    Site Not Available

  • Takeda Site 16

    Jung-Gu, Daegu Gwang'yeogsi
    Korea, Republic of

    Site Not Available

  • Takeda Site 19

    Suwon, Gyeonggido 16247
    Korea, Republic of

    Site Not Available

  • Takeda Site 21

    Seoul, Seoul Teugbyeolsi 3080
    Korea, Republic of

    Site Not Available

  • Takeda Site 18

    Madrid, 28046
    Spain

    Site Not Available

  • Takeda Site 14

    Redwood City, California 94063-3132
    United States

    Site Not Available

  • Takeda Site 10

    Santa Ana, California 92705-8519
    United States

    Site Not Available

  • Takeda Site 1

    Colorado Springs, Colorado 80918-3408
    United States

    Site Not Available

  • Takeda Site 13

    Brandon, Florida 33511-5719
    United States

    Site Not Available

  • Takeda Site 3

    Orlando, Florida 32803-1468
    United States

    Active - Recruiting

  • Takeda Site 4

    Saint Louis, Missouri 63123-6968
    United States

    Active - Recruiting

  • Takeda Site 8

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Takeda Site 6

    Huntersville, North Carolina 28078-5082
    United States

    Active - Recruiting

  • Takeda Site 5

    Cincinnati, Ohio 45245-4500
    United States

    Active - Recruiting

  • Takeda Site 2

    Columbia, South Carolina 29201-2923
    United States

    Active - Recruiting

  • Takeda Site 7

    San Antonio, Texas 78229-4849
    United States

    Active - Recruiting

  • Takeda Site 11

    Norfolk, Virginia 23510-1021
    United States

    Site Not Available

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