A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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) \[inclusive\].
• The participant has a documented, current diagnosis of NT2.
Locations
United States
Alabama
Takeda Site 36
RECRUITING
Auburn
Arizona
Takeda Site 39
RECRUITING
Chandler
California
Takeda Site 40
RECRUITING
Chula Vista
Takeda Site 14
RECRUITING
Redwood City
Takeda Site 10
RECRUITING
Santa Ana
Colorado
Takeda Site 1
RECRUITING
Colorado Springs
Florida
Takeda Site 48
NOT_YET_RECRUITING
Bradenton
Takeda Site 13
RECRUITING
Brandon
Takeda Site 46
NOT_YET_RECRUITING
Jacksonville
Takeda Site 35
RECRUITING
Miami
Takeda Site 44
RECRUITING
Miami
Takeda Site 3
RECRUITING
Orlando
Takeda Site 33
RECRUITING
Orlando
Georgia
Takeda Site 32
RECRUITING
Atlanta
Maryland
Takeda Site 49
NOT_YET_RECRUITING
Bowie
Michigan
Takeda Site 50
NOT_YET_RECRUITING
Lansing
Takeda Site 34
RECRUITING
Lathrup Village
Missouri
Takeda Site 4
RECRUITING
St Louis
North Carolina
Takeda Site 8
RECRUITING
Denver
Takeda Site 6
RECRUITING
Huntersville
Takeda Site 41
RECRUITING
Winston-salem
New Jersey
Takeda Site 37
RECRUITING
Middletown
Ohio
Takeda Site 5
RECRUITING
Cincinnati
Takeda Site 45
NOT_YET_RECRUITING
Cleveland
South Carolina
Takeda Site 2
RECRUITING
Columbia
Texas
Takeda Site 38
RECRUITING
Austin
Takeda Site 43
WITHDRAWN
Dallas
Takeda Site 42
NOT_YET_RECRUITING
El Paso
Takeda Site 47
NOT_YET_RECRUITING
Mansfield
Takeda Site 7
RECRUITING
San Antonio
Virginia
Takeda Site 11
RECRUITING
Norfolk
Other Locations
China
Takeda Site 28
RECRUITING
Beijing
Takeda Site 51
RECRUITING
Changchun
Takeda Site 29
RECRUITING
Guangzhou
Takeda Site 27
RECRUITING
Shanghai
France
Takeda Site 17
WITHDRAWN
Montpellier
Takeda Site 15
RECRUITING
Paris
Italy
Takeda Site 23
RECRUITING
Bologna
Takeda Site 22
RECRUITING
Rome
Takeda Site 31
RECRUITING
Verona
Japan
Takeda Site 52
RECRUITING
Fukuoka
Takeda Site 53
NOT_YET_RECRUITING
Isahaya-shi
Takeda Site 24
RECRUITING
Kohoku-ku, Yokohama-shi
Takeda Site 9
RECRUITING
Kumamoto
Takeda Site 20
RECRUITING
Shinjuku-ku
Takeda Site 26
RECRUITING
Sumida-ku
Takeda Site 30
RECRUITING
Urasoe-shi
Takeda Site 12
RECRUITING
Yodogawa-ku, Osaka-shi
Republic of Korea
Takeda Site 16
RECRUITING
Junggu
Takeda Site 21
RECRUITING
Seoul
Takeda Site 19
RECRUITING
Suwon
Spain
Takeda Site 18
RECRUITING
Madrid
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2025-05-06
Estimated Completion Date:2026-08-20
Participants
Target number of participants:88
Treatments
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.