Long-Term Safety and Tolerability Study of TAK-360 in Adults with Narcolepsy Type 1, Type 2, or Idiopathic Hypersomnia

What this Trial Is About

Researchers are studying TAK-360 in adults with central hypersomnia conditions, including narcolepsy type 1 NT1, type 2 NT2, and idiopathic hypersomnia IH. These conditions cause excessive daytime sleepiness, with NT1 also involving sudden muscle weakness called cataplexy. The study focuses on evaluating the long-term safety and tolerability of TAK-360 over an extended period in participants who previously took part in parent TAK-360 trials. Participants will receive TAK-360 tablets at the same or closest available dose from their previous parent study, continuing for up to approximately five years. Those who received a placebo in the parent trials will be given an active TAK-360 dose in this long-term extension. Placebo tablets may be used only to maintain dose blinding during the study. The trial involves multiple clinic visits for ongoing monitoring. Throughout the study, participants will undergo various assessments, including tracking treatment-emergent adverse events over up to five years. Researchers will also measure changes in sleepiness scores, maintenance of wakefulness, and severity scales specific to IH and narcolepsy subtypes. Cataplexy episodes will be recorded using participant diaries. Safety evaluations and adherence monitoring will occur regularly to ensure participant well-being during the long-term follow-up.

A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia