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A Study of TAK-861 in Participants With Narcolepsy Type 2 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of TAK-861 in Participants With Narcolepsy Type 2

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

NCT05687916•Takeda

View on ClinicalTrials.gov

Summary

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Detailed Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy \[Narcolepsy Type 2 (NT2)\]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861. The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-861 Dose 1 * TAK-861 Dose 2 * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

Eligibility

Age

16 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
•Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
•\- The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.
•Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

Exclusion Criteria

•The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
•The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
•The participant has one or more of the following psychiatric disorders:
•1. Any current unstable psychiatric disorder.
•2. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
•3. Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
•4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
•The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years ago), intracranial aneurysm, or arteriovenous malformation.
•The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Locations (56)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Mayo Clinic Arizona-PPDS

Scottsdale, Arizona, United States

Stanford Center for Sleep Sciences and Medicine

Redwood City, California, United States

SDS Clinical Trials, Inc.

Santa Ana, California, United States

Delta Waves LLC - Hunt - PPDS

Colorado Springs, Colorado, United States

Florida Pediatric Research Institute

Orlando, Florida, United States

Neurotrials Research

Atlanta, Georgia, United States

Georgia Neuro Center

Gainesville, Georgia, United States

Neurocare Inc.

Newton, Massachusetts, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Key Dates

Start Date

January 9, 2023

Primary Completion Date

December 13, 2023

Completion Date

December 25, 2023

Last Updated

January 9, 2025

Enrollment

ACTUAL participants

Conditions

Narcolepsy Type 2

Interventions

Placebo

DRUG

TAK-861 2 mg

DRUG

TAK-861 2 mg and 5 mg

DRUG

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

NCT06952699

Narcolepsy Type 2

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A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783

Narcolepsy Type 2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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