drugset / Trial / NCT06470828

A Study of TAK-861 for the Treatment of Narcolepsy Type 1

NCT06470828

Phase 3 Completed 168 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

Summary

The main aim of this study is to learn how effective TAK-861 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 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 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.

Timeline

Start
2024-07-02
Primary completion
2025-06-03
Completion
2025-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject oveporexton Small molecule Oral

Indications