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Study identifier: NCT06812078 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Condition: Idiopathic Hypersomnia  ·  Sponsor: Takeda

PhasePhase 2
Planned participants96
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Takeda Contact  ·  +1-877-825-3327  ·  medinfoUS@takeda.com

Always discuss trial participation with your own doctor first.

Locations (29)

Takeda Site 11Redwood City, California, United StatesRecruiting
Takeda Site 10Santa Ana, California, United StatesRecruiting
Takeda Site 27Colorado Springs, Colorado, United StatesRecruiting
Takeda Site 19Brandon, Florida, United StatesRecruiting
Takeda Site 14Winter Park, Florida, United StatesRecruiting
Takeda Site 29St Louis, Missouri, United StatesRecruiting
Takeda Site 16Denver, North Carolina, United StatesRecruiting
Takeda Site 15Huntersville, North Carolina, United StatesRecruiting
Takeda Site 12Cincinnati, Ohio, United StatesRecruiting
Takeda Site 17Cincinnati, Ohio, United StatesRecruiting
Takeda Site 13Columbia, South Carolina, United StatesRecruiting
Takeda Site 18San Antonio, Texas, United StatesRecruiting

+ 17 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06812078