A Study of TAK-861 for the Treatment of Narcolepsy Type 1
brief summary
The main aim of this study is to learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 (oveporexton) is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 (oveporexton) has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861 (oveporexton).
detailed description
The drug being tested in this study is called TAK-861 (oveporexton). TAK-861 (oveporexton) is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1).
The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:
1. TAK-861 Dose 1 2. TAK-861 Dose 2 3. Placebo
The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.
official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)