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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy

In brief

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.

Key facts

Study ID

NCT07363720

Run by

Takeda

People needed

88

Starts

2026-01-29

Expected to finish

2026-10-02

Last updated by the study team

2026-07-08

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 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).

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 (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.

Where it is running

• Takeda Site 15 — Redwood City, California, United States (enrolling)
• Takeda Site 19 — Brandon, Florida, United States (enrolling)
• Takeda Site 22 — Miami, Florida, United States (enrolling)
• Takeda Site 23 — Southfield, Michigan, United States (enrolling)
• Takeda Site 20 — Middletown, New Jersey, United States (enrolling)
• Takeda Site 24 — Durham, North Carolina, United States (enrolling)
• Takeda Site 25 — Winston-Salem, North Carolina, United States (enrolling)
• Takeda Site 16 — Cincinnati, Ohio, United States (enrolling)
• Takeda Site 18 — Cleveland, Ohio, United States (enrolling)
• Takeda Site 17 — Columbia, South Carolina, United States (enrolling)
• Takeda Site 21 — Austin, Texas, United States (enrolling)
• Takeda Site 1 — Montpellier, France (enrolling)
• Takeda Site 2 — Paris, France (enrolling)
• Takeda Site 3 — Toulouse, France (enrolling)
• Takeda Site 4 — Schwerin, Mecklenburg-Vorpommern, Germany (enrolling)
• Takeda Site 5 — Berlin, Germany (enrolling)
• Takeda Site 6 — Bologna, Emilia-Romagna, Italy (enrolling)
• Takeda Site 7 — Rome, Lazio, Italy (enrolling)
• Takeda Site 8 — Heemstede, Netherlands (enrolling)
• Takeda Site 12 — Vitoria-Gasteiz, Alava, Spain (enrolling)
• Takeda Site 11 — Alzira, Valencia, Spain (enrolling)
• Takeda Site 10 — Barcelona, Spain (enrolling)
• Takeda Site 9 — Madrid, Spain (enrolling)
• Takeda Site 13 — Barmelweid, Canton of Aargau, Switzerland (enrolling)
• Takeda Site 14 — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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