Phase
Condition
Narcolepsy
Treatment
TAK-861
Clinical Study ID
Ages 16-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- Participant with a diagnosis of NT1 who has completed a controlled study withTAK-861, and for whom the investigator has no clinical objection to theirenrollment.
Exclusion
Exclusion criteria:
Participant has a treatment-emergent adverse event (TEAE) that remains severe at thetime of rollover related to the study drug from the parent study or discontinuedbecause of TEAEs in the parent study.
Participant has a risk of suicide according to endorsement of item 4 or 5 on theColumbia Suicide Severity Rating Scale (C-SSRS).
The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN).
Participant has a current medical disorder, other than narcolepsy with or withoutcataplexy, associated with excessive daytime sleepiness (EDS).
Participant has current active major depressive episode (MDE) or has had an activeMDE in the past 6 months.
Participant has developed (within the last 6 months) gastrointestinal disease thatis expected to influence the absorption of drugs.
Participant has epilepsy or history of seizure.
Participant has any other medical condition, such as anxiety, depression, heartdisease, or significant hepatic, pulmonary, or renal disease, that requires them totake excluded medications.
Participant has a history of cerebral ischemia, transient ischemic attack (<5 yearsago), or cerebral hemorrhage.
Participant has a history of myocardial infarction, clinically significant coronaryartery disease, clinically significant angina, clinically significant cardiac rhythmabnormality, or heart failure.
Participant has a history of cancer in the past 5 years.
Study Design
Study Description
Connect with a study center
Woolcock Institute of Medical Research
Glebe, New South Wales 2037
AustraliaActive - Recruiting
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa 00380
FinlandActive - Recruiting
CHRU Dijon Hopital General
Dijon, Cote-d'Or 21079
FranceSite Not Available
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne 31000
FranceActive - Recruiting
CHU Gui De Chauliac
Montpellier, Herault 34090
FranceActive - Recruiting
CHU de Grenoble
La Tronche, Isere 38700
FranceActive - Recruiting
Hopital Roger Salengro
Lille, Nord 59000
FranceSite Not Available
Hopital de la Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
Hotel Dieu de Paris Hospital
Paris, 75181
FranceSite Not Available
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bayern 93053
GermanyActive - Recruiting
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern 19053
GermanyActive - Recruiting
Universitaet Witten-Herdecke
Witten, Nordrhein-Westfalen 58453
GermanySite Not Available
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rheinland-Pfalz 55131
GermanySite Not Available
Charite - Universitatsmedizin Berlin
Berlin, 10117
GermanyActive - Recruiting
Klinische Forschung Hamburg
Hamburg, 20253
GermanyActive - Recruiting
Fondazione PTV Policlinico Tor Vergata
Roma, Lazio 00133
ItalyActive - Recruiting
Ospedale San Raffaele S.r.l. - PPDS
Milano, Lombardia 20127
ItalySite Not Available
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise 86077
ItalyActive - Recruiting
Ospedale Bellaria
Bellaria, 40139
ItalyActive - Recruiting
Ehime University Hospital
Tōon, Ehime 791-0295
JapanSite Not Available
Inoue Hospital
Fukuoka, Hukuoka 810-0044
JapanSite Not Available
Fukuoka Urazoe Clinic
Kitakyushu, Hukuoka 802-0084
JapanSite Not Available
Kurume University Hospital
Kurume-Shi, Hukuoka 830-0011
JapanActive - Recruiting
Howakai Kuwamizu Hospital
Kumamoto-Shi, Kumamoto 862-0954
JapanActive - Recruiting
YOU ARIYOSHI Sleep Clinic
Nagasaki-Shi, Nagasaki 850-0045
JapanActive - Recruiting
Gokeikai Osaka Kaisei Hospital
Osaka-Shi, Osaka 532-0003
JapanActive - Recruiting
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo 112-0012
JapanActive - Recruiting
Akita University Hospital
Kodaira-Shi, Tokyo 187-0031
JapanSite Not Available
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo 187-8551
JapanSite Not Available
Yoyogi Sleep Disorder Center
Shibuya-Ku, Tokyo 151-0053
JapanSite Not Available
Aichi Medical University Hospital
Nagakute, 480-1195
JapanActive - Recruiting
RESM respiratory and sleep medical-care clinic
Yokohama, 222-0033
JapanSite Not Available
Kempenhaeghe - PPDS
Heeze, Noord-Brabant 5591 VE
NetherlandsActive - Recruiting
Slaap-Waakcentrum SEIN Heemstede
Heemstede, Noord-Holland 2103 SW
NetherlandsActive - Recruiting
University of Oslo
Oslo, 0450
NorwayActive - Recruiting
Hospital Universitario Araba Santiago
Vitoria, Alava 01009
SpainActive - Recruiting
Hospital General de Castello
Castellón De La Plana, Castellon 12004
SpainActive - Recruiting
Hospital de La Ribera
Alzira, Valencia 46600
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
SpainActive - Recruiting
Hospital La Milagrosa
Madrid, 28046
SpainSite Not Available
Hospital Vithas Madrid Arturo Soria
Madrid, 28046
SpainActive - Recruiting
Instituto de Investigaciones del Sueno
Madrid, 28036
SpainActive - Recruiting
Sahlgrenska University Hospital
Goteborg, Vastra Gotalands Lan 413 46
SwedenActive - Recruiting
Klinik Barmelweid AG
Barmelweid, Aargau (de) 5017
SwitzerlandActive - Recruiting
Neurocenter of Southern Switzerland
Lugano, Ticino (it) 6900
SwitzerlandActive - Recruiting
Universitaetsspital Bern - Inselspital
Bern, 43017-3521
SwitzerlandActive - Recruiting
Sleep Disorders Center of Alabama
Birmingham, Alabama 35213
United StatesActive - Recruiting
Mayo Clinic Arizona - PPDS
Scottsdale, Arizona 85259
United StatesSite Not Available
Stanford Center for Sleep Sciences and Medicine
Redwood City, California 94063
United StatesActive - Recruiting
SDS Clinical Trials, Inc.
Santa Ana, California 92705
United StatesActive - Recruiting
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado 80918
United StatesActive - Recruiting
Florida Pediatric Research Institute
Orlando, Florida 32803
United StatesActive - Recruiting
Neurotrials Research
Atlanta, Georgia 30342
United StatesActive - Recruiting
Georgia Neuro Center
Gainesville, Georgia 30501
United StatesActive - Recruiting
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United StatesSite Not Available
Center For Sleep and Wake Disorders
Chevy Chase, Maryland 20815
United StatesSite Not Available
Neurocare Inc
Newton, Massachusetts 02459
United StatesActive - Recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan 48377
United StatesActive - Recruiting
St. Lukes Sleep Medicine and Research Center
Chesterfield, Missouri 63017
United StatesSite Not Available
University of Colorado Hospital
Saint Louis, Missouri 63108
United StatesSite Not Available
Research Carolina Elite
Denver, North Carolina 28037
United StatesActive - Recruiting
ARSM Research, LLC
Huntersville, North Carolina 28078
United StatesActive - Recruiting
CTI Research Center
Cincinnati, Ohio 45212
United StatesActive - Recruiting
Intrepid Research
Cincinnati, Ohio 45227
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
Ohio Sleep Medicine Institute
Dublin, Ohio 43017
United StatesActive - Recruiting
Medical University of South Carolina - PPDS
Charleston, South Carolina 29425
United StatesActive - Recruiting
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
United StatesActive - Recruiting
Comprehensive Sleep Medicine Associates - Sugar Land
Houston, Texas 77030
United StatesSite Not Available
Sleep Therapy and Research Center
San Antonio, Texas 78229
United StatesActive - Recruiting
Children's Specialty Group
Norfolk, Virginia 23510
United StatesActive - Recruiting
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