NCT06505031

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in participants with narcolepsy with cataplexy (narcolepsy type 1 \[NT1\]). The study will enroll approximately 93 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups: 1. TAK-861 2. Placebo The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Conditions

• Narcolepsy Type 1

Interventions

Type	Name	Description
DRUG	TAK-861	Oral tablet.
DRUG	Placebo	TAK-861-matching placebo tablet.

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2024-07-17
• Last updated: 2025-09-15

Locations

28 sites across 11 countries: Australia, Austria, Belgium, China, Finland, France, Italy, Poland, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study