Condition: Idiopathic Hypersomnia · Sponsor: Takeda
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.
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| Takeda Site 11 | Redwood City, California, United States | Recruiting |
| Takeda Site 10 | Santa Ana, California, United States | Recruiting |
| Takeda Site 27 | Colorado Springs, Colorado, United States | Recruiting |
| Takeda Site 19 | Brandon, Florida, United States | Recruiting |
| Takeda Site 14 | Winter Park, Florida, United States | Recruiting |
| Takeda Site 29 | St Louis, Missouri, United States | Recruiting |
| Takeda Site 16 | Denver, North Carolina, United States | Recruiting |
| Takeda Site 15 | Huntersville, North Carolina, United States | Recruiting |
| Takeda Site 12 | Cincinnati, Ohio, United States | Recruiting |
| Takeda Site 17 | Cincinnati, Ohio, United States | Recruiting |
| Takeda Site 13 | Columbia, South Carolina, United States | Recruiting |
| Takeda Site 18 | San Antonio, Texas, United States | Recruiting |
+ 17 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06812078