Recruiting
Phase 2
Phase 3

TAK-861

Sponsor:

Takeda

Code:

NCT05816382

Conditions

Narcolepsy Type 1

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

TAK-861

Study Details

Brief summary:

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Conditions

Narcolepsy Type 1

Study ID

NCT05816382

Start date

Apr 5, 2023

Status verified date

Mar, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Inclusion criteria:

1\. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria:

1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
7. Participant has epilepsy or history of seizure.
8. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
9. Participant has a history of cerebral ischemia, transient ischemic attack (less than (<) 5 years ago), or cerebral hemorrhage.
10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
11. Participant has a history of cancer in the past 5 years.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-861

In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.

Interventions

TAK-861

TAK-861 tablets

Primary outcome measure

  • Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years) ]

Central Contacts and Locations

Central contacts

Locations

Sleep Disorders Center of Alabama

Recruiting

Birmingham, Alabama, United States, 35213

Stanford Center for Sleep Sciences and Medicine

Recruiting

Redwood City, California, United States, 94063

SDS Clinical Trials, Inc.

Recruiting

Santa Ana, California, United States, 92705

Delta Waves LLC - Hunt - PPDS

Recruiting

Colorado Springs, Colorado, United States, 80918

Florida Pediatric Research Institute

Recruiting

Orlando, Florida, United States, 32803

Neurotrials Research

Recruiting

Atlanta, Georgia, United States, 30342

Georgia Neuro Center

Recruiting

Gainesville, Georgia, United States, 30501

Neurocare Inc

Recruiting

Newton, Massachusetts, United States, 02459

Henry Ford Medical Center - Columbus

Recruiting

Novi, Michigan, United States, 48377

Research Carolina Elite

Recruiting

Denver, North Carolina, United States, 28037

ARSM Research, LLC

Recruiting

Huntersville, North Carolina, United States, 28078

CTI Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Intrepid Research

Recruiting

Cincinnati, Ohio, United States, 45227

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Ohio Sleep Medicine Institute

Recruiting

Dublin, Ohio, United States, 43017

Medical University of South Carolina - PPDS

Recruiting

Charleston, South Carolina, United States, 29425

Bogan Sleep Consultants, LLC

Recruiting

Columbia, South Carolina, United States, 29201

Sleep Therapy and Research Center

Recruiting

San Antonio, Texas, United States, 78229

Children's Specialty Group

Recruiting

Norfolk, Virginia, United States, 23510

More Information

Sponsor

Takeda

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Takeda on 2026-03-05.