A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 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 if they get a lot of sleep at night. People with IH may struggle to wake up, feel tired despite naps, and experience difficulty focusing or completing daily tasks. This trial is designed to evaluate the safety, tolerability, and potential benefits of TAK-360, a drug that acts like orexin, a brain chemical that helps maintain wakefulness, in adults with IH. Participants in the study will be randomly assigned to receive either TAK-360 tablets or placebo tablets, which look the same but contain no active medicine, for a period of 4 weeks. This randomized, double-blind design means neither participants nor researchers will know who receives the active drug or placebo during the trial, helping to fairly assess TAK-360s effects. During the study, participants will be monitored for any treatment-related side effects up to 8 weeks. Researchers will measure changes in sleepiness using the Epworth Sleepiness Scale and changes in IH symptoms using the Idiopathic Hypersomnia Severity Scale at the start and after 4 weeks of treatment. The trial lasts several weeks, including follow-up, to understand how TAK-360 affects safety, wakefulness, and symptom severity in IH.

A Study of TAK-360 in Adults With Idiopathic Hypersomnia