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 (30) 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
California
Takeda Site 14
NOT_YET_RECRUITING
Redwood City
Takeda Site 10
NOT_YET_RECRUITING
Santa Ana
Colorado
Takeda Site 1
NOT_YET_RECRUITING
Colorado Springs
Florida
Takeda Site 13
NOT_YET_RECRUITING
Brandon
Takeda Site 3
RECRUITING
Orlando
Missouri
Takeda Site 4
RECRUITING
St Louis
North Carolina
Takeda Site 8
ACTIVE_NOT_RECRUITING
Denver
Takeda Site 6
RECRUITING
Huntersville
Ohio
Takeda Site 5
RECRUITING
Cincinnati
South Carolina
Takeda Site 2
RECRUITING
Columbia
Texas
Takeda Site 7
RECRUITING
San Antonio
Virginia
Takeda Site 11
NOT_YET_RECRUITING
Norfolk
Other Locations
China
Takeda Site 28
NOT_YET_RECRUITING
Beijing
Takeda Site 29
NOT_YET_RECRUITING
Guangzhou
Takeda Site 27
NOT_YET_RECRUITING
Shanghai
France
Takeda Site 17
NOT_YET_RECRUITING
Montpellier
Takeda Site 15
NOT_YET_RECRUITING
Paris
Hong Kong Special Administrative Region
Takeda Site 25
NOT_YET_RECRUITING
New Territories
Italy
Takeda Site 23
NOT_YET_RECRUITING
Bellaria
Takeda Site 22
NOT_YET_RECRUITING
Rome
Japan
Takeda Site 20
NOT_YET_RECRUITING
Bunkyo-ku
Takeda Site 9
NOT_YET_RECRUITING
Kumamoto
Takeda Site 12
NOT_YET_RECRUITING
Osaka
Takeda Site 26
NOT_YET_RECRUITING
Sumida-ku
Takeda Site 30
NOT_YET_RECRUITING
Urasoe
Takeda Site 24
NOT_YET_RECRUITING
Yokohama
Republic of Korea
Takeda Site 16
NOT_YET_RECRUITING
Junggu
Takeda Site 21
NOT_YET_RECRUITING
Seoul
Takeda Site 19
NOT_YET_RECRUITING
Suwon
Spain
Takeda Site 18
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2025-05-06
Estimated Completion Date:2026-04-23
Participants
Target number of participants:40
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.