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

Completed · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy Type 1

In brief

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

Key facts

Study ID

NCT06470828

Run by

Takeda

People needed

168

Starts

2024-07-02

Expected to finish

2025-06-03

Last updated by the study team

2025-07-01

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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 it is running

• Takeda Site 39 — Redwood City, California, United States
• Takeda Site 31 — Santa Ana, California, United States
• Takeda Site 18 — Upland, California, United States
• Takeda Site 4 — Orlando, Florida, United States
• Takeda Site 3 — Atlanta, Georgia, United States
• Takeda Site 45 — Boston, Massachusetts, United States
• Takeda Site 5 — St Louis, Missouri, United States
• Takeda Site 2 — Denver, North Carolina, United States
• Takeda Site 6 — Cincinnati, Ohio, United States
• Takeda Site 42 — Cleveland, Ohio, United States
• Takeda Site 49 — Danville, Pennsylvania, United States
• Takeda Site 1 — Columbia, South Carolina, United States
• Takeda Site 44 — Dallas, Texas, United States
• Takeda Site 10 — Norfolk, Virginia, United States
• Takeda Site 21 — Ottawa, Ontario, Canada
• Takeda Site 11 — Toronto, Ontario, Canada
• Takeda Site 50 — Montreal, Quebec, Canada
• Takeda Site 25 — Montpellier, Herault, France
• Takeda Site 43 — Toulouse, Midi-Pyrenees, France
• Takeda Site 40 — Lyon, France
• Takeda Site 29 — Paris, France
• Takeda Site 47 — Regensberg, Bavaria, Germany
• Takeda Site 34 — Berlin, Germany
• Takeda Site 26 — Schwerin, Germany
• Takeda Site 48 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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