A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Start Date
5/6/2025
Completion Date
11/30/2026
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
Age Range: 18 years to 70 years
Interventions
TAK-360
Placebo
Conditions
Locations
Takeda Site 36
Auburn, Alabama 36832
United States
Takeda Site 39
Chandler, Arizona 85224
United States
Takeda Site 40
Chula Vista, California 91910
United States
Takeda Site 14
Redwood City, California 94063-3132
United States
Takeda Site 10
Santa Ana, California 92705-8519
United States
Takeda Site 1
Colorado Springs, Colorado 80918-3408
United States
Takeda Site 48
Bradenton, Florida 34209
United States
Takeda Site 13
Brandon, Florida 33511-5719
United States
Takeda Site 46
Jacksonville, Florida 32209
United States
Takeda Site 44
Miami, Florida 33155
United States
Takeda Site 35
Miami, Florida 33176
United States
Takeda Site 3
Orlando, Florida 32803-1468
United States
Takeda Site 33
Orlando, Florida 32807
United States
Takeda Site 32
Atlanta, Georgia 30328
United States
Takeda Site 49
Bowie, Maryland 20715
United States
Takeda Site 50
Lansing, Michigan 48911
United States
Takeda Site 34
Lathrup Village, Michigan 48076
United States
Takeda Site 4
St Louis, Missouri 63123-6968
United States
Takeda Site 37
Middletown, New Jersey 07748
United States
Takeda Site 8
Denver, North Carolina 28037
United States
Takeda Site 6
Huntersville, North Carolina 28078-5082
United States
Takeda Site 41
Winston-Salem, North Carolina 27103
United States
Takeda Site 5
Cincinnati, Ohio 45245-4500
United States
Takeda Site 45
Cleveland, Ohio 44106
United States
Takeda Site 2
Columbia, South Carolina 29201-2923
United States
Takeda Site 38
Austin, Texas 78731
United States
Takeda Site 43
Dallas, Texas 75235
United States
Takeda Site 42
El Paso, Texas 79912
United States
Takeda Site 47
Mansfield, Texas 76063
United States
Takeda Site 7
San Antonio, Texas 78229-4849
United States
Takeda Site 11
Norfolk, Virginia 23510-1021
United States
Takeda Site 28
Beijing, Beijing Municipality 100053
China
Takeda Site 29
Guangzhou, Guangzhou 510515
China
Takeda Site 51
Changchun, Jilin 130021
China
Takeda Site 27
Shanghai, Shanghai Municipality 200040
China
Takeda Site 17
Montpellier, Hérault 34090
France
Takeda Site 15
Paris, 75013
France
Takeda Site 22
Rome, Lazio 133
Italy
Takeda Site 31
Verona, Veneto 37134
Italy
Takeda Site 23
Bologna, 40139
Italy
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa 222-0033
Japan
Takeda Site 9
Kumamoto, Kumamoto 862-0954
Japan
Takeda Site 53
Isahaya-shi, Nagasaki 854-0081
Japan
Takeda Site 30
Urasoe-Shi, Okinawa 901-2132
Japan
Takeda Site 20
Shinjuku-ku, Tokyo 162-0851
Japan
Takeda Site 26
Sumida-Ku, Tokyo 130-0004
Japan
Takeda Site 52
Fukuoka, 812-0025
Japan
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka 532-0003
Japan
Takeda Site 16
Junggu, Daegu Gwang'yeogsi
South Korea
Takeda Site 19
Suwon, Gyeonggido 16247
South Korea
Takeda Site 21
Seoul, Seoul Teugbyeolsi 3080
South Korea
Takeda Site 18
Madrid, 28046
Spain