A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Key facts
- Where
- Austin, Brandon, Cincinnati, Cleveland, Columbia, Durham, Miami, Middletown, Redwood City, Southfield, and Winston-Salem, United StatesSee the 11 sites
- Phase
- Phase 3
Where in United States
- Austin, TexasHospital not named in the registryNo longer taking part
- Brandon, FloridaHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Columbia, South CarolinaHospital not named in the registryNo longer taking part
- Durham, North CarolinaHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Middletown, New JerseyHospital not named in the registryNo longer taking part
- Redwood City, CaliforniaHospital not named in the registryNo longer taking part
- Southfield, MichiganHospital not named in the registryNo longer taking part
- Winston-Salem, North CarolinaHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- Takeda
- Trial code
- NCT07363720EU 2024-519466-44-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
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.
Inclusion: The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2); The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1; The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1*06:02) or results from radioimmunoassay indicate the participant's CSF OX/hypocretin-1 concentration is ≤110 pg/mL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
Exclusion: The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS; The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease; The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs; The participant has a history of cancer in the past 5 years; The participant has a clinically significant history of head injury or head trauma; The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood); The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.