Actively Recruiting
A Double-Blind, Randomized Withdrawal Trial Evaluating TAK-861 Tablets for Treating Narcolepsy Type 1 with Cataplexy
Led by Takeda · Updated on 2026-05-08
88
Participants Needed
18
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of TAK-861 for treating narcolepsy type 1 (NT1), a condition that includes narcolepsy with cataplexy. This Phase 3 trial aims to see how well TAK-861 works and whether its benefits last over time. The study also monitors any side effects or adverse events related to taking or stopping the medication in people with NT1. All participants will start by taking TAK-861 tablets during an open-label treatment period. After this period, those who meet certain criteria will be randomly assigned to continue TAK-861 at their current dose or switch to placebo tablets in a double-blind randomized withdrawal period lasting up to 4 weeks. If symptoms worsen during this withdrawal phase and sleepiness scores rise above a set level, participants will stop the study treatment and may join a separate long-term extension study or be followed for 4 weeks after their last dose. Participants will be assessed using the Epworth Sleepiness Scale to measure daytime sleepiness and will undergo monitoring for safety and side effects throughout the study. The trial is planned to include about 88 participants worldwide, aged 16 to 70 years, and involves careful follow-up to observe how the treatment impacts their narcolepsy symptoms over time.
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Takeda Site 1
Redwood City, California, United States, 94063
Actively Recruiting
2
Takeda Site 4
Brandon, Florida, United States, 33511
Actively Recruiting
3
Takeda Site 6
Miami, Florida, United States, 33155
Actively Recruiting
4
Takeda Site 7
Southfield, Michigan, United States, 48075
Actively Recruiting
5
Takeda Site 16
Middletown, New Jersey, United States, 07748
Actively Recruiting
6
Takeda Site 17
Durham, North Carolina, United States, 27710-4000
Actively Recruiting
7
Takeda Site 18
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
8
Takeda Site 2
Cincinnati, Ohio, United States, 45245
Actively Recruiting
9
Takeda Site 15
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Takeda Site 3
Columbia, South Carolina, United States, 29201
Actively Recruiting
11
Takeda Site 5
Austin, Texas, United States, 78731
Actively Recruiting
12
Takeda Site 8
Montpellier, France, 34295
Actively Recruiting
13
Takeda Site 9
Paris, France, 75013
Actively Recruiting
14
Takeda Site 10
Toulouse, France, 31059
Actively Recruiting
15
Takeda Site 11
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Actively Recruiting
16
Takeda Site 12
Heemstede, Netherlands, 2103 SW
Actively Recruiting
17
Takeda Site 13
Barmelweid, Canton of Aargau, Switzerland, 5017
Actively Recruiting
18
Takeda Site 14
Bern, Switzerland, 3010
Actively Recruiting
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
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here