A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. 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 IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo 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 or equal 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 IH.

Locations
United States
California
Takeda Site 11
RECRUITING
Redwood City
Takeda Site 10
RECRUITING
Santa Ana
Colorado
Takeda Site 27
RECRUITING
Colorado Springs
Florida
Takeda Site 19
RECRUITING
Brandon
Takeda Site 14
RECRUITING
Winter Park
Missouri
Takeda Site 29
RECRUITING
St Louis
North Carolina
Takeda Site 16
ACTIVE_NOT_RECRUITING
Denver
Takeda Site 15
RECRUITING
Huntersville
Ohio
Takeda Site 12
RECRUITING
Cincinnati
Takeda Site 17
RECRUITING
Cincinnati
South Carolina
Takeda Site 13
RECRUITING
Columbia
Texas
Takeda Site 18
RECRUITING
San Antonio
Virginia
Takeda Site 28
RECRUITING
Norfolk
Other Locations
France
Takeda Site 1
RECRUITING
Montpellier
Takeda Site 3
RECRUITING
Nantes
Takeda Site 2
RECRUITING
Paris
Hong Kong Special Administrative Region
Takeda Site 4
RECRUITING
Shatin
Italy
Takeda Site 5
RECRUITING
Bologna
Takeda Site 6
RECRUITING
Pozzilli
Takeda Site 7
NOT_YET_RECRUITING
Rome
Takeda Site 26
NOT_YET_RECRUITING
Verona
Japan
Takeda Site 24
RECRUITING
Bunkyo-ku
Takeda Site 25
RECRUITING
Fukuoka-shi Hakata-ku
Takeda Site 22
RECRUITING
Kohoku-ku, Yokohama-shi
Takeda Site 20
RECRUITING
Kumamoto
Takeda Site 23
RECRUITING
Kurume-shi
Takeda Site 21
RECRUITING
Yodogawa-ku, Osaka-shi
Spain
Takeda Site 8
RECRUITING
Madrid
Takeda Site 9
RECRUITING
Vitoria-gasteiz
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2026-02-19
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov