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

StatusActive, Not Recruiting
PhasePhase 3
SponsorTakeda
Started2026-01-29
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-09-02
notable
Enrollment closed, study ongoing
2026-09-02
minor
Final enrollment: 98 participants (planned 88)
2026-07-09
minor
Trial sites expanded: 18 → 25 locations
2026-05-09
minor
Trial sites expanded: 7 → 18 locations
Trial Details
NCT Number NCT07363720
Lead Sponsor Takeda
Conditions Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Enrollment 98 participants
Start Date 2026-01-29
Primary Completion 2026-10-02 (estimated)
Study Completion 2026-10-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-01