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A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Sponsor: Takeda
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.
Official title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Key Details
Gender
All
Age Range
16 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2023-04-05
Completion Date
2028-02-28
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
TAK-861
TAK-861 tablets
Locations (52)
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, United States
Florida Pediatric Research Institute
Orlando, Florida, United States
Neurotrials Research
Atlanta, Georgia, United States
Georgia Neuro Center
Gainesville, Georgia, United States
Neurocare Inc
Newton, Massachusetts, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Research Carolina Elite
Denver, North Carolina, United States
ARSM Research, LLC
Huntersville, North Carolina, United States
CTI Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Medical University of South Carolina - PPDS
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa, Finland
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, France
CHU Gui De Chauliac
Montpellier, Herault, France
CHU de Grenoble
La Tronche, Isere, France
Hopital de la Pitie Salpetriere
Paris, France
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria, Germany
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Charite - Universitatsmedizin Berlin
Berlin, Germany
Klinische Forschung Hamburg
Hamburg, Germany
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, Italy
Ospedale Bellaria
Bellaria, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Howakai Kuwamizu Hospital
Kumamoto, Kumamoto, Japan
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki, Japan
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, Japan
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan
Aichi Medical University Hospital
Nagakute, Japan
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland, Netherlands
University of Oslo
Oslo, Norway
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava, Spain
Hospital General de Castello
Castellon, Castellon, Spain
Hospital de La Ribera
Alzira, Valencia, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Instituto de Investigaciones del Sueno
Madrid, Spain
Hospital Vithas Madrid Arturo Soria
Madrid, Spain
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Klinik Barmelweid AG
Barmelweid, Aargau (de), Switzerland
Neurocenter of Southern Switzerland
Lugano, Ticino (it), Switzerland
Universitaetsspital Bern - Inselspital
Bern, Switzerland