Clinical Trial

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
Protocol Amendment History 2 changes
notable Trial sites expanded: 18 -> 25 locations 2026-07-09
notable Trial sites expanded: 7 -> 18 locations 2026-05-09
Trial Details
NCT Number NCT07363720
Lead Sponsor Takeda
Conditions Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Enrollment 88 participants
Start Date 2026-01-29
Primary Completion 2026-10-02 (estimated)
Study Completion 2026-10-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-08