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NCT05816382Possibly a fitRecruiting

Testing TAK-861 for narcolepsy type 1 sleepiness

Narcolepsy Type 1

Part of Brain & nervous system clinical trials.

This Phase 2/3 study tests TAK-861 in people with narcolepsy type 1 (NT1) who already completed an earlier TAK-861 trial. The goal is to see if the medicine remains safe and effective for ongoing central (brain-related) sleepiness problems.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
500 people
Ages
16 years to 70 years
Study type
Interventional

Who can take part

  • You have a diagnosis of narcolepsy type 1 (NT1)
  • You finished a previous controlled TAK-861 study, and the study doctor has no concerns about you joining
  • You do NOT have a severe side effect still ongoing from the earlier TAK-861 study, or you were not stopped due to side effects
  • Your suicide risk is not flagged as high on the C-SSRS questions
  • Your liver blood tests (ALT and AST) are not more than 1.5 times the normal upper limit
  • You do not have other illnesses causing excessive daytime sleepiness or needing excluded medicines

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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