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Clinical Trials in the USA / NCT05816382
Recruiting Phase 2/3

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

NCT05816382 · tracked via the Priya Life Science USA tracker
Sponsor
Takeda
Phase
Phase 2/3
Started
2023-04-05
Last updated
2026-03-05

Condition(s) studied

Narcolepsy Type 1

Investigational drug(s) / intervention(s)

TAK-861

TAK-861: TAK-861 tablets

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Sleep Disorders Center of Alabama Birmingham Alabama Recruiting
Stanford Center for Sleep Sciences and Medicine Redwood City California Recruiting
SDS Clinical Trials, Inc. Santa Ana California Recruiting
Delta Waves LLC - Hunt - PPDS Colorado Springs Colorado Recruiting
Florida Pediatric Research Institute Orlando Florida Recruiting
Neurotrials Research Atlanta Georgia Recruiting
Georgia Neuro Center Gainesville Georgia Recruiting
Neurocare Inc Newton Massachusetts Recruiting
Henry Ford Medical Center - Columbus Novi Michigan Recruiting
Research Carolina Elite Denver North Carolina Recruiting
ARSM Research, LLC Huntersville North Carolina Recruiting
CTI Research Center Cincinnati Ohio Recruiting
Intrepid Research Cincinnati Ohio Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Recruiting
Ohio Sleep Medicine Institute Dublin Ohio Recruiting
Medical University of South Carolina - PPDS Charleston South Carolina Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina Recruiting
Sleep Therapy and Research Center San Antonio Texas Recruiting
Children's Specialty Group Norfolk Virginia Recruiting
Woolcock Institute of Medical Research Glebe New South Wales Recruiting
Terveystalo Helsinki Sleep Clinic Helsinki Uusimaa Recruiting
Hopital Pierre-Paul Riquet Toulouse Haute-Garonne Recruiting
CHU Gui De Chauliac Montpellier Herault Recruiting
CHU de Grenoble La Tronche Isere Recruiting
Hopital de la Pitie Salpetriere Paris France Recruiting
Universitaet Regensburg am Bezirksklinikum Regensburg Bavaria Recruiting
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH Schwerin Mecklenburg-Vorpommern Recruiting
Charite - Universitatsmedizin Berlin Berlin Germany Recruiting
Klinische Forschung Hamburg Hamburg Germany Recruiting
Fondazione PTV Policlinico Tor Vergata Rome Lazio Recruiting
Istituto Neurologico Mediterraneo Neuromed Pozzilli Molise Recruiting
Ospedale Bellaria Bellaria Italy Recruiting
Kurume University Hospital Kurume-Shi Hukuoka Recruiting
Howakai Kuwamizu Hospital Kumamoto Kumamoto Recruiting
YOU ARIYOSHI Sleep Clinic Nagasaki Nagasaki Recruiting
Gokeikai Osaka Kaisei Hospital Osaka Osaka Recruiting
Koishikawa Tokyo Hospital Bunkyo-Ku Tokyo Recruiting
Aichi Medical University Hospital Nagakute Japan Recruiting
Kempenhaeghe - PPDS Heeze North Brabant Recruiting
Slaap-Waakcentrum SEIN Heemstede Heemstede North Holland Recruiting

+ 12 more sites — see the full list on the official registry below.

More Takeda trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05816382 on ClinicalTrials.gov ↗ ← All trials in the USA