What is TAK-861 studying for narcolepsy type 1?

TAK-861 is being studied to understand its safety and how it may affect symptoms like excessive daytime sleepiness and cataplexy in people with narcolepsy type 1. This research aims to provide long-term information about using TAK-861 under medical supervision.

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

Individuals aged 16 to 70 with a diagnosis of narcolepsy type 1 who previously completed a TAK-861 trial may be eligible. People with certain medical conditions like recent major depression, epilepsy, or significant heart issues may not qualify. 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 expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 16Years - 70Years

All Genders

ID05816382

Long-term Safety Study of TAK-861 for Treating Narcolepsy Type 1

Led by Takeda · Updated on 2026-03-05

500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

CONDITIONS

Brief Title

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Who Can Participate

Age: 16Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant with a diagnosis of narcolepsy type 1 who has completed a controlled trial with TAK-861
Investigator has no clinical objection to their enrollment

You will not qualify if you...

Participant has a severe treatment-emergent adverse event from the parent trial related to TAK-861 or discontinued due to such events
Risk of suicide based on Columbia Suicide Severity Rating Scale
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal
Current medical disorder causing excessive daytime sleepiness other than narcolepsy
Current active major depressive episode or one within the past 6 months
Recent gastrointestinal disease affecting drug absorption
Epilepsy or history of seizures
Medical conditions requiring excluded medications such as anxiety, depression, heart disease, or significant liver, lung, or kidney disease
History of cerebral ischemia, transient ischemic attack less than 5 years ago, or cerebral hemorrhage
History of myocardial infarction, significant coronary artery disease, angina, cardiac rhythm abnormality, or heart failure
History of cancer within the past 5 years

Research Team

Takeda Contact

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