A Phase 2 Study to Evaluate the Safety and Effectiveness of TAK-360 Compared to Placebo in Adults with Idiopathic Hypersomnia

What this Trial Is About

Idiopathic Hypersomnia IH is a condition where adults feel extremely sleepy during the day, especially in the morning, even after sleeping a lot at night. This condition can cause difficulty waking up, trouble focusing, and symptoms like dizziness. Researchers are studying TAK-360, a drug that acts like orexin, a brain chemical that helps keep people awake. The study aims to understand how safe and tolerable TAK-360 is for adults with IH and to find the right dose to help with wakefulness. Participants in the study will be randomly assigned to receive either TAK-360 tablets or placebo tablets that look the same but contain no active medicine. Both treatments will be taken orally for 4 weeks. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo, to fairly evaluate the effects of TAK-360. During the study, participants will be monitored for safety and side effects up to 8 weeks. Researchers will measure changes in daytime sleepiness using the Epworth Sleepiness Scale and symptoms using the Idiopathic Hypersomnia Severity Scale at the start and after 4 weeks. The trial will also track any treatment-emergent adverse events. The total participation time may include screening, treatment, and follow-up assessments over several weeks.

A Study of TAK-360 in Adults With Idiopathic Hypersomnia