Actively Recruiting
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Led by Takeda · Updated on 2026-05-27
88
Participants Needed
52
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Narcolepsy Type 2 (NT2) is a lifelong condition that causes excessive daytime sleepiness, sudden sleep episodes, and difficulty staying awake, affecting daily activities like driving and working. This trial is studying TAK-360, a medicine that acts like orexin, a brain chemical that helps keep people awake. The study aims to evaluate the safety, tolerability, and proper dosage of TAK-360 in adults with NT2. Participants will be randomly assigned to receive either TAK-360 or a placebo tablet orally for 4 weeks. The placebo looks like TAK-360 but contains no active medicine. This randomized, double-blinded trial compares TAK-360 with placebo to understand its effects on wakefulness and safety in adults with NT2. During the study, researchers will monitor side effects and measure sleepiness using tests like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at the start and after 4 weeks. Participants will be observed for up to 15 weeks to track any treatment-related adverse events. This trial helps determine how TAK-360 is tolerated and its impact on staying awake for adults with NT2.
CONDITIONS
Brief 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
- Body mass index (BMI) is between 16 and 38 kg/m² inclusive
- Documented, current diagnosis of Narcolepsy Type 2 (NT2)
- Age between 18 and 70 years
You will not qualify if you...
- Current medical disorder causing excessive daytime sleepiness other than NT2
- Medically significant thyroid disease
- History of cancer within past 5 years, except treated and stable basal cell carcinoma or carcinoma in situ
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody/antigen at screening
- Clinically significant history of head injury or head 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive TAK-360 or matching placebo tablets orally for 4 weeks to evaluate safety, tolerability, and efficacy.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 52 locations
1
Takeda Site 36
Auburn, Alabama, United States, 36832
Actively Recruiting
2
Takeda Site 39
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Takeda Site 40
Chula Vista, California, United States, 91910
Actively Recruiting
4
Takeda Site 14
Redwood City, California, United States, 94063-3132
Actively Recruiting
5
Takeda Site 10
Santa Ana, California, United States, 92705-8519
Actively Recruiting
6
Takeda Site 1
Colorado Springs, Colorado, United States, 80918-3408
Actively Recruiting
7
Takeda Site 48
Bradenton, Florida, United States, 34209
Not Yet Recruiting
8
Takeda Site 13
Brandon, Florida, United States, 33511-5719
Actively Recruiting
9
Takeda Site 46
Jacksonville, Florida, United States, 32209
Not Yet Recruiting
10
Takeda Site 44
Miami, Florida, United States, 33155
Not Yet Recruiting
11
Takeda Site 35
Miami, Florida, United States, 33176
Actively Recruiting
12
Takeda Site 3
Orlando, Florida, United States, 32803-1468
Actively Recruiting
13
Takeda Site 33
Orlando, Florida, United States, 32807
Actively Recruiting
14
Takeda Site 32
Atlanta, Georgia, United States, 30328
Actively Recruiting
15
Takeda Site 49
Bowie, Maryland, United States, 20715
Not Yet Recruiting
16
Takeda Site 50
Lansing, Michigan, United States, 48911
Not Yet Recruiting
17
Takeda Site 34
Lathrup Village, Michigan, United States, 48076
Actively Recruiting
18
Takeda Site 4
St Louis, Missouri, United States, 63123-6968
Actively Recruiting
19
Takeda Site 37
Middletown, New Jersey, United States, 07748
Actively Recruiting
20
Takeda Site 8
Denver, North Carolina, United States, 28037
Actively Recruiting
21
Takeda Site 6
Huntersville, North Carolina, United States, 28078-5082
Actively Recruiting
22
Takeda Site 41
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
23
Takeda Site 5
Cincinnati, Ohio, United States, 45245-4500
Actively Recruiting
24
Takeda Site 45
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
25
Takeda Site 2
Columbia, South Carolina, United States, 29201-2923
Actively Recruiting
26
Takeda Site 38
Austin, Texas, United States, 78731
Actively Recruiting
27
Takeda Site 43
Dallas, Texas, United States, 75235
Not Yet Recruiting
28
Takeda Site 42
El Paso, Texas, United States, 79912
Not Yet Recruiting
29
Takeda Site 47
Mansfield, Texas, United States, 76063
Not Yet Recruiting
30
Takeda Site 7
San Antonio, Texas, United States, 78229-4849
Actively Recruiting
31
Takeda Site 11
Norfolk, Virginia, United States, 23510-1021
Actively Recruiting
32
Takeda Site 28
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
33
Takeda Site 29
Guangzhou, Guangzhou, China, 510515
Actively Recruiting
34
Takeda Site 51
Changchun, Jilin, China, 130021
Actively Recruiting
35
Takeda Site 27
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
36
Takeda Site 17
Montpellier, Hérault, France, 34090
Withdrawn
37
Takeda Site 15
Paris, France, 75013
Actively Recruiting
38
Takeda Site 22
Rome, Lazio, Italy, 133
Actively Recruiting
39
Takeda Site 31
Verona, Veneto, Italy, 37134
Actively Recruiting
40
Takeda Site 23
Bologna, Italy, 40139
Actively Recruiting
41
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa, Japan, 222-0033
Actively Recruiting
42
Takeda Site 9
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
43
Takeda Site 53
Isahaya-shi, Nagasaki, Japan, 854-0081
Not Yet Recruiting
44
Takeda Site 30
Urasoe-Shi, Okinawa, Japan, 901-2132
Actively Recruiting
45
Takeda Site 20
Shinjuku-ku, Tokyo, Japan, 162-0851
Actively Recruiting
46
Takeda Site 26
Sumida-Ku, Tokyo, Japan, 130-0004
Actively Recruiting
47
Takeda Site 52
Fukuoka, Japan, 812-0025
Actively Recruiting
48
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka, Japan, 532-0003
Actively Recruiting
49
Takeda Site 16
Junggu, Daegu Gwang'yeogsi, South Korea
Actively Recruiting
50
Takeda Site 19
Suwon, Gyeonggido, South Korea, 16247
Actively Recruiting
51
Takeda Site 21
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
52
Takeda Site 18
Madrid, Spain, 28046
Actively Recruiting
Research Team
T
Takeda 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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