Isahaya

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.

Narcolepsy Type 2 NT2 is a lifelong condition causing excessive daytime sleepiness, difficulty staying awake, and problems with concentration and memory, impacting daily life activities. Researchers are evaluating TAK-360, a drug that acts like orexin, a brain chemical that promotes wakefulness, to understand its safety, tolerability, and ability to help adults with NT2 stay awake. This is a Phase 2, randomized, double-blind, placebo-controlled study to find the right dosage of TAK-360. Participants will be randomly assigned to receive either TAK-360 tablets or matching placebo tablets orally for 4 weeks. TAK-360 is being studied to assess its effects compared to placebo. The study uses a parallel design and includes a 4-week treatment period where participants take the assigned tablets daily. During the study, participants will be monitored for treatment-emergent adverse events for up to 15 weeks. Researchers will assess wakefulness using tools like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at baseline and after 4 weeks of treatment. Safety, tolerability, and efficacy data will be collected throughout the study, which runs until November 2026.