drugset / Trial / NCT06505031

A Study of TAK-861 in People With Narcolepsy Type 1

NCT06505031

Phase 3 Completed 105 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
2024-10-08
Primary completion
2025-06-04
Completion
2025-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject oveporexton Small molecule 2 mg Oral

Indications