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

RecruitingPhase 2/3

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Who can join

Ages 16 to 70 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Takeda · Participants: 500 · Started: Apr 5, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05816382

Locations in the U.S.

AlabamaSleep Disorders Center of Alabama, Birmingham
CaliforniaStanford Center for Sleep Sciences and Medicine, Redwood City
SDS Clinical Trials, Inc., Santa Ana
ColoradoDelta Waves LLC - Hunt - PPDS, Colorado Springs
FloridaFlorida Pediatric Research Institute, Orlando
GeorgiaNeurotrials Research, Atlanta
Georgia Neuro Center, Gainesville
MassachusettsNeurocare Inc, Newton
MichiganHenry Ford Medical Center - Columbus, Novi
North CarolinaResearch Carolina Elite, Denver
ARSM Research, LLC, Huntersville
OhioCTI Research Center, Cincinnati
Intrepid Research, Cincinnati
The Cleveland Clinic Foundation, Cleveland
Ohio Sleep Medicine Institute, Dublin
South CarolinaMedical University of South Carolina - PPDS, Charleston
Bogan Sleep Consultants, LLC, Columbia
TexasSleep Therapy and Research Center, San Antonio
VirginiaChildren's Specialty Group, Norfolk

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.