What is TAK-861 studying for narcolepsy type 1 with cataplexy?

TAK-861 is being studied to see how well it treats narcolepsy type 1 with cataplexy and whether its effects last over time. This study also checks the safety of TAK-861 and monitors any side effects. Takeda is sponsoring this research to better understand the treatment's impact.

Who may be eligible for this narcolepsy type 1 clinical trial?

People aged 16 to 70 with a diagnosis of narcolepsy type 1 and specific genetic or biomarker markers may qualify. Participants should have a body mass index between 18 and 40 and no other medical causes of excessive sleepiness. Please review eligibility criteria for more details.

Is there any cost to participate in this narcolepsy type 1 clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 16Years - 70Years

All Genders

ID07363720

Evaluating TAK-861 for Treating Narcolepsy Type 1 with Cataplexy Assessing Effectiveness and Safety in a Double-Blind Randomized Withdrawal Study

Led by Takeda · Updated on 2026-07-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying TAK-861 to evaluate its effectiveness and safety for treating narcolepsy type 1 with cataplexy. This phase 3 trial aims to determine whether TAK-861 helps control symptoms and if its benefits last over time, as well as to monitor any side effects related to taking or stopping the drug. Participants will first take TAK-861 openly for several months during the open-label treatment period. Those who meet certain criteria will then be randomly assigned to continue TAK-861 at the same dose or switch to placebo for up to 4 weeks in a double-blind randomized withdrawal period. If symptoms worsen during this period, participants may stop treatment and join a long-term extension study or be followed for 4 weeks after their last dose. During the study, participants will undergo assessments including the Epworth Sleepiness Scale, Maintenance of Wakefulness Test, cataplexy rate tracking, cognitive tests, and patient-reported outcomes. Safety will be monitored throughout the trial, which lasts approximately 31 weeks from screening to study end. The study is conducted at multiple centers worldwide.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 70Years

All Genders

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
Positive for HLA-DQB1*06:02 gene or cerebrospinal fluid hypocretin-1 concentration ≤110 pg/mL
Age between 16 and 70 years

You will not qualify if you...

Presence of any other medical disorder causing excessive daytime sleepiness
History of myocardial infarction, significant liver, thyroid, heart rhythm, coronary artery or heart failure conditions
Unstable cardiovascular, pulmonary, renal, or gastrointestinal disease
Recent (within 6 months) gastrointestinal disease affecting drug absorption
History of cancer within the past 5 years
Significant history of head injury or trauma
History of epilepsy, seizure, or convulsion except a single febrile seizure in childhood
History of cerebral ischemia, transient ischemic attack (less than 5 years), intracranial aneurysm, or arteriovenous malformation

Research Team

Takeda Contact

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