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

Recruiting now · Phase 2/Phase 3

Conditions studied: Narcolepsy Type 1

In brief

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.

Key facts

Study ID

NCT05816382

Run by

Takeda

People needed

500

Starts

2023-04-05

Expected to finish

2028-02-28

Last updated by the study team

2026-03-05

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Center for Sleep Sciences and Medicine — Redwood City, California, United States (enrolling)
• SDS Clinical Trials, Inc. — Santa Ana, California, United States (enrolling)
• Delta Waves LLC - Hunt - PPDS — Colorado Springs, Colorado, United States (enrolling)
• Florida Pediatric Research Institute — Orlando, Florida, United States (enrolling)
• Neurotrials Research — Atlanta, Georgia, United States (enrolling)
• Georgia Neuro Center — Gainesville, Georgia, United States (enrolling)
• Neurocare Inc — Newton, Massachusetts, United States (enrolling)
• Henry Ford Medical Center - Columbus — Novi, Michigan, United States (enrolling)
• Research Carolina Elite — Denver, North Carolina, United States (enrolling)
• ARSM Research, LLC — Huntersville, North Carolina, United States (enrolling)
• CTI Research Center — Cincinnati, Ohio, United States (enrolling)
• Intrepid Research — Cincinnati, Ohio, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Ohio Sleep Medicine Institute — Dublin, Ohio, United States (enrolling)
• Medical University of South Carolina - PPDS — Charleston, South Carolina, United States (enrolling)
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States (enrolling)
• Sleep Therapy and Research Center — San Antonio, Texas, United States (enrolling)
• Children's Specialty Group — Norfolk, Virginia, United States (enrolling)
• Woolcock Institute of Medical Research — Glebe, New South Wales, Australia (enrolling)
• Terveystalo Helsinki Sleep Clinic — Helsinki, Uusimaa, Finland (enrolling)
• Hopital Pierre-Paul Riquet — Toulouse, Haute-Garonne, France (enrolling)
• CHU Gui De Chauliac — Montpellier, Herault, France (enrolling)
• CHU de Grenoble — La Tronche, Isere, France (enrolling)
• Hopital de la Pitie Salpetriere — Paris, France (enrolling)
• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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