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CompletedPhase 3

A Study of TAK-861 for the Treatment of Narcolepsy Type 1

Key facts

Who runs it
Takeda
Where
Atlanta, Boston, Cincinnati, Cleveland, Columbia, Dallas, Danville, Denver, Norfolk, Orlando, Phoenix, Redwood City, Santa Ana, St Louis, and Upland, United StatesSee the 15 sitesAlso in 10 other countries, 38 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
168 people enrolled
Started
2 Jul 2024
Ended
3 Jun 2025
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Oveporexton
  • Placebo
Record updated
31 August 2026

Who can take part

Age
16 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (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 has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR)
  • The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay]

Who cannot take part

  • 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
  • The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation

Where in United States

Also in 10 other countries, 38 sites

  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital 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
  • Dallas, TexasHospital not named in the registryNo longer taking part
  • Danville, PennsylvaniaHospital not named in the registryNo longer taking part
  • Denver, North CarolinaHospital not named in the registryNo longer taking part
  • Norfolk, VirginiaHospital not named in the registryNo longer taking part
  • Orlando, FloridaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Redwood City, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • St Louis, MissouriHospital not named in the registryNo longer taking part
  • Upland, CaliforniaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

The main aim of this study is to learn how effective TAK-861 (oveporexton) 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 (oveporexton) 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 (oveporexton) 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 (oveporexton).

The 3 groups in the trial

  • PlaceboPlacebo, for comparison

    Participants received oveporexton (OVE)-matching placebo tablets, orally, for 12 weeks.

  • OVE 1 mg BIDTreatment being tested

    Participants received OVE tablets, 1 milligram (mg), orally, for 12 weeks.

    Treatment: Oveporexton

  • OVE 2 mg BIDTreatment being tested

    Participants received OVE tablets, 2 mg, orally, for 12 weeks.

    Treatment: Oveporexton

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Publications
Record updated
31 August 2026