Actively Recruiting
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Led by Takeda · Updated on 2026-02-12
88
Participants Needed
30
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant weighs at least 40 kilograms and has a body mass index between 16 and 38 kg/m2 inclusive
- Documented, current diagnosis of Narcolepsy Type 2 (NT2)
You will not qualify if you...
- Current medical disorder causing excessive daytime sleepiness other than NT2
- Medically significant thyroid disease
- History of cancer in the past 5 years, except treated and stable carcinoma in situ or with medical monitor approval
- Positive test for Hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody/antigen at screening
- Clinically significant history of head injury or trauma
- History of epilepsy, seizure, or convulsion (except a single febrile seizure in childhood)
- History of cerebral ischemia, transient ischemic attack within 5 years, intracranial aneurysm, or arteriovenous malformation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Takeda Site 14
Redwood City, California, United States, 94063-3132
Actively Recruiting
2
Takeda Site 10
Santa Ana, California, United States, 92705-8519
Actively Recruiting
3
Takeda Site 1
Colorado Springs, Colorado, United States, 80918-3408
Actively Recruiting
4
Takeda Site 13
Brandon, Florida, United States, 33511-5719
Actively Recruiting
5
Takeda Site 3
Orlando, Florida, United States, 32803-1468
Actively Recruiting
6
Takeda Site 4
St Louis, Missouri, United States, 63123-6968
Actively Recruiting
7
Takeda Site 8
Denver, North Carolina, United States, 28037
Actively Recruiting
8
Takeda Site 6
Huntersville, North Carolina, United States, 28078-5082
Actively Recruiting
9
Takeda Site 5
Cincinnati, Ohio, United States, 45245-4500
Actively Recruiting
10
Takeda Site 2
Columbia, South Carolina, United States, 29201-2923
Actively Recruiting
11
Takeda Site 7
San Antonio, Texas, United States, 78229-4849
Actively Recruiting
12
Takeda Site 11
Norfolk, Virginia, United States, 23510-1021
Actively Recruiting
13
Takeda Site 28
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
14
Takeda Site 29
Guangzhou, Guangzhou, China, 510515
Actively Recruiting
15
Takeda Site 27
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
16
Takeda Site 17
Montpellier, Hérault, France, 34090
Withdrawn
17
Takeda Site 15
Paris, France, 75013
Actively Recruiting
18
Takeda Site 22
Rome, Lazio, Italy, 133
Actively Recruiting
19
Takeda Site 31
Verona, Veneto, Italy, 37134
Actively Recruiting
20
Takeda Site 23
Bologna, Italy, 40139
Actively Recruiting
21
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa, Japan, 222-0033
Actively Recruiting
22
Takeda Site 9
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
23
Takeda Site 30
Urasoe-Shi, Okinawa, Japan, 901-2132
Actively Recruiting
24
Takeda Site 20
Shinjuku-ku, Tokyo, Japan, 162-0851
Actively Recruiting
25
Takeda Site 26
Sumida-Ku, Tokyo, Japan, 130-0004
Actively Recruiting
26
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka, Japan, 532-0003
Actively Recruiting
27
Takeda Site 16
Junggu, Daegu Gwang'yeogsi, South Korea
Actively Recruiting
28
Takeda Site 19
Suwon, Gyeonggido, South Korea, 16247
Actively Recruiting
29
Takeda Site 21
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
30
Takeda Site 18
Madrid, Spain, 28046
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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