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A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for Narcolepsy With Cataplexy (Narcolepsy Type 1)
Led by Takeda · Updated on 2026-05-08
88
Participants Needed
18
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the drug TAK-861 for treating narcolepsy type 1, also known as narcolepsy with cataplexy. The study aims to understand how well TAK-861 works and whether its effects last over time. It also looks at the safety of TAK-861 and any side effects that might occur when starting or stopping the medication. All participants start by taking TAK-861 during an open-label treatment period. After this, those who meet specific criteria are randomly assigned to either continue TAK-861 at the same dose or switch to a placebo for up to 4 weeks in a double-blind randomized withdrawal period. If participants’ symptoms worsen during this time, they may stop the study treatment and have the option to join a long-term extension study or be followed for 4 weeks after stopping the drug. Participants will be involved for about 31 weeks, undergoing assessments of sleepiness using the Epworth Sleepiness Scale and other tests like the Maintenance of Wakefulness Test and Psychomotor Vigilance Test. Researchers will monitor symptom changes, cataplexy rates, and any adverse events throughout. Safety and efficacy data are collected regularly to understand how TAK-861 affects narcolepsy symptoms over time.
CONDITIONS
Brief 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 kg/m²
- Diagnosed with narcolepsy type 1 according to ICSD-3 or ICSD-3-TR criteria
- Positive for HLA-DQB1*06:02 genotype or cerebrospinal fluid OX/hypocretin-1 concentration of 110 pg/mL or less (or less than one-third of normal values)
You will not qualify if you...
- Having another medical disorder causing excessive daytime sleepiness
- History of myocardial infarction
- History of significant liver, thyroid, heart rhythm, or heart failure disorders
- Unstable cardiovascular, pulmonary, kidney, or gastrointestinal diseases
- Current or recent (within 6 months) gastrointestinal disease affecting drug absorption
- History of cancer within the last 5 years
- Significant history of head injury or trauma
- History of epilepsy, seizure, or convulsion (except single febrile seizure in childhood)
- History of cerebral ischemia, transient ischemic attack within 5 years, intracranial aneurysm, or arteriovenous malformation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 16 weeks
Participants take TAK-861 to assess effectiveness and safety for narcolepsy type 1.
Duration - Up to 4 weeks
Participants who meet criteria are randomized to receive TAK-861 or placebo to evaluate maintenance of treatment effect.
Up to 4 weeks of treatment with visits as scheduled during withdrawal period
Duration - 4 weeks after last dose
Participants who discontinue treatment are followed for safety and symptom monitoring.
Follow-up visits during 4 weeks after treatment ends
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
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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