A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Takeda · NCT05816382
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 16–70 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 500
- US sites recruiting
- 19
- Study start
- April 5, 2023
- Record last updated
- March 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: TAK-861
Conditions: Narcolepsy Type 1
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- 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
- 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.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- Participant has epilepsy or history of seizure.
- 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.
- Participant has a history of cerebral ischemia, transient ischemic attack (less than (\<) 5 years ago), or cerebral hemorrhage.
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- Participant has a history of cancer in the past 5 years.
Recruiting US locations
Sleep Disorders Center of Alabama
Birmingham, AL 35213
Stanford Center for Sleep Sciences and Medicine
Redwood City, CA 94063
SDS Clinical Trials, Inc.
Santa Ana, CA 92705
Delta Waves LLC - Hunt - PPDS
Colorado Springs, CO 80918
Florida Pediatric Research Institute
Orlando, FL 32803
Neurotrials Research
Atlanta, GA 30342
Georgia Neuro Center
Gainesville, GA 30501
Neurocare Inc
Newton, MA 02459
Henry Ford Medical Center - Columbus
Novi, MI 48377
Research Carolina Elite
Denver, NC 28037
ARSM Research, LLC
Huntersville, NC 28078
CTI Research Center
Cincinnati, OH 45212
Intrepid Research
Cincinnati, OH 45227
The Cleveland Clinic Foundation
Cleveland, OH 44195
Ohio Sleep Medicine Institute
Dublin, OH 43017
Medical University of South Carolina - PPDS
Charleston, SC 29425
Bogan Sleep Consultants, LLC
Columbia, SC 29201
Sleep Therapy and Research Center
San Antonio, TX 78229
Children's Specialty Group
Norfolk, VA 23510
Study contacts (from the official record)
- Takeda Contact · +1-877-825-3327 · medinfoUS@takeda.com
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