Safety and Tolerability of TAK-360 for Treating Narcolepsy Type 1 With Cataplexy in Adults

What this Trial Is About

Narcolepsy Type 1 NT1 is a sleep disorder characterized by excessive daytime sleepiness and sudden muscle weakness while conscious, known as cataplexy. This trial evaluates the safety and tolerability of TAK-360 in adults with NT1. Participants must stop their current NT1 medications before starting the study treatment. They may be randomly assigned to receive either TAK-360 or a placebo, which looks identical but contains no active medicine. The trial is sponsored by Takeda and uses a randomized, double-blind design. Participants will take TAK-360 or matching placebo tablets orally. The study includes multiple parts where participants receive either TAK-360 or placebo in a parallel design. After the treatment period lasting up to about 28 weeks, participants will be monitored for an additional two weeks. Following study treatment, participants can resume their usual NT1 medications. Throughout the trial, participants will visit the clinic multiple times for evaluations. Researchers will assess treatment-emergent adverse events, sleep latency using the Maintenance of Wakefulness Test, sleepiness levels with the Epworth Sleepiness Scale, and weekly cataplexy rates. Safety and tolerability will be closely monitored, and participants usual care will continue after the study ends.

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)