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A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Led by Takeda · Updated on 2026-05-08
88
Participants Needed
18
Research Sites
35 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18 and 40 kilograms per square meter
- Diagnosed with narcolepsy type 1 (NT1) according to ICSD-3 or ICSD-3-TR criteria
- Positive for HLA-DQB1*06:02 genotype or CSF OX/hypocretin-1 concentration ≤110 pg/mL (or less than one-third of normal mean values)
You will not qualify if you...
- Current medical disorders other than narcolepsy with cataplexy that cause excessive daytime sleepiness
- History of myocardial infarction, clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality, or heart failure
- Any unstable cardiovascular, pulmonary, renal, or gastrointestinal disease
- Current or recent (within 6 months) gastrointestinal disease affecting drug absorption
- History of cancer within the past 5 years
- Clinically significant history of head injury or head trauma
- History of epilepsy, seizures, or convulsions (except a single febrile seizure in childhood)
- History of cerebral ischemia, transient ischemic attack within 5 years, intracranial aneurysm, or arteriovenous malformation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Takeda Site 1
Redwood City, California, United States, 94063
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2
Takeda Site 4
Brandon, Florida, United States, 33511
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3
Takeda Site 6
Miami, Florida, United States, 33155
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4
Takeda Site 7
Southfield, Michigan, United States, 48075
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5
Takeda Site 16
Middletown, New Jersey, United States, 07748
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6
Takeda Site 17
Durham, North Carolina, United States, 27710-4000
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7
Takeda Site 18
Winston-Salem, North Carolina, United States, 27103
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8
Takeda Site 2
Cincinnati, Ohio, United States, 45245
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9
Takeda Site 15
Cleveland, Ohio, United States, 44195
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10
Takeda Site 3
Columbia, South Carolina, United States, 29201
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11
Takeda Site 5
Austin, Texas, United States, 78731
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12
Takeda Site 8
Montpellier, France, 34295
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13
Takeda Site 9
Paris, France, 75013
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14
Takeda Site 10
Toulouse, France, 31059
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15
Takeda Site 11
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
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16
Takeda Site 12
Heemstede, Netherlands, 2103 SW
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17
Takeda Site 13
Barmelweid, Canton of Aargau, Switzerland, 5017
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18
Takeda Site 14
Bern, Switzerland, 3010
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Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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