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 trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
Exclusion
Exclusion criteria:
Participant has a treatment-emergent adverse event (TEAE) that remains severe at thetime of rollover related to the trial intervention from the parent trial ordiscontinued because of TEAEs in the parent trial.
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) 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 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 (less than (<) 5 years ago), 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
Woolcock Institute of Medical Research
Glebe 2165450, New South Wales 2155400 2037
AustraliaSite Not Available
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa 00380
FinlandActive - Recruiting
Terveystalo Helsinki Sleep Clinic
Helsinki 658225, Uusimaa 830709 00380
FinlandSite Not Available
CHRU Dijon Hopital General
Dijon, Cote-d'Or 21079
FranceSite Not Available
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne 31000
FranceActive - Recruiting
Hopital Pierre-Paul Riquet
Toulouse 2972315, Haute-Garonne 31000
FranceSite Not Available
CHU Gui De Chauliac
Montpellier, Herault 34090
FranceActive - Recruiting
CHU Gui De Chauliac
Montpellier 2992166, Herault 34090
FranceSite Not Available
CHU de Grenoble
La Tronche, Isere 38700
FranceActive - Recruiting
CHU de Grenoble
La Tronche 3006131, Isere 38700
FranceSite Not Available
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
Hopital de la Pitie Salpetriere
Paris 2988507, 75013
FranceSite Not Available
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria 93053
GermanyActive - Recruiting
Universitaet Regensburg am Bezirksklinikum
Regensburg 2849483, Bavaria 2951839 93053
GermanySite Not Available
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern 19053
GermanyActive - Recruiting
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin 2834282, Mecklenburg-Vorpommern 2872567 19053
GermanySite Not Available
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
Charite - Universitatsmedizin Berlin
Berlin 2950159, 10117
GermanySite Not Available
Klinische Forschung Hamburg
Hamburg, 20253
GermanyActive - Recruiting
Klinische Forschung Hamburg
Hamburg 2911298, 20253
GermanySite Not Available
Fondazione PTV Policlinico Tor Vergata
Roma, Lazio 00133
ItalySite Not Available
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio 00133
ItalyActive - Recruiting
Fondazione PTV Policlinico Tor Vergata
Rome 3169070, Lazio 3174976 00133
ItalySite Not Available
Ospedale San Raffaele S.r.l. - PPDS
Milano, Lombardia 20127
ItalySite Not Available
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise 86077
ItalyActive - Recruiting
Istituto Neurologico Mediterraneo Neuromed
Pozzilli 3170006, Molise 3173222 86077
ItalySite Not Available
Ospedale Bellaria
Bellaria, 40139
ItalyActive - Recruiting
Ospedale Bellaria
Bellaria 8952367, 40139
ItalySite Not Available
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, Kumamoto 862-0954
JapanActive - Recruiting
Howakai Kuwamizu Hospital
Kumamoto-Shi, Kumamoto 862-0954
JapanSite Not Available
Howakai Kuwamizu Hospital
Kumamoto 1858421, Kumamoto 1858419 862-0954
JapanSite Not Available
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki 850-0045
JapanActive - Recruiting
YOU ARIYOSHI Sleep Clinic
Nagasaki-Shi, Nagasaki 850-0045
JapanSite Not Available
YOU ARIYOSHI Sleep Clinic
Nagasaki 1856177, Nagasaki 1856156 850-0045
JapanSite Not Available
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka 532-0003
JapanActive - Recruiting
Gokeikai Osaka Kaisei Hospital
Osaka-Shi, Osaka 532-0003
JapanSite Not Available
Gokeikai Osaka Kaisei Hospital
Osaka 1853909, Osaka 1853904 532-0003
JapanSite Not Available
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
Aichi Medical University Hospital
Nagakute 11611613, 480-1195
JapanSite Not Available
RESM respiratory and sleep medical-care clinic
Yokohama, 222-0033
JapanSite Not Available
Kempenhaeghe - PPDS
Heeze, North Brabant 5591 VE
NetherlandsActive - Recruiting
Kempenhaeghe - PPDS
Heeze 2754618, North Brabant 2749990 5591 VE
NetherlandsSite Not Available
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland 2103 SW
NetherlandsActive - Recruiting
Slaap-Waakcentrum SEIN Heemstede
Heemstede 2754692, North Holland 2749879 2103 SW
NetherlandsSite Not Available
University of Oslo
Oslo, 0450
NorwayActive - Recruiting
University of Oslo
Oslo 3143244, 0450
NorwaySite Not Available
Hospital Universitario Araba Santiago
Vitoria, Alava 01009
SpainSite Not Available
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava 01009
SpainActive - Recruiting
Hospital Universitario Araba Santiago
Vitoria-Gasteiz 3104499, Alava 01009
SpainSite Not Available
Hospital General de Castello
Castellon, Castellon 12004
SpainActive - Recruiting
Hospital General de Castello
Castellon 2519752, Castellon 12004
SpainSite Not Available
Hospital General de Castello
Castellón De La Plana, Castellon 12004
SpainSite Not Available
Hospital de La Ribera
Alzira, Valencia 46600
SpainActive - Recruiting
Hospital de La Ribera
Alzira 2522129, Valencia 2593113 46600
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona 3128760, 08036
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona 3128760, 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
Hospital Vithas Madrid Arturo Soria
Madrid 3117735, 28046
SpainActive - Recruiting
Instituto de Investigaciones del Sueno
Madrid 3117735, 28036
SpainSite Not Available
Sahlgrenska University Hospital
Goteborg, Vastra Gotalands Lan 413 46
SwedenSite Not Available
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County 413 46
SwedenActive - Recruiting
Sahlgrenska University Hospital
Gothenburg 2711537, Västra Götaland County 3337386 413 46
SwedenSite Not Available
Klinik Barmelweid AG
Barmelweid, Aargau (de) 5017
SwitzerlandActive - Recruiting
Klinik Barmelweid AG
Barmelweid 8469091, Aargau (de) 5017
SwitzerlandSite Not Available
Neurocenter of Southern Switzerland
Lugano, Ticino (it) 6900
SwitzerlandActive - Recruiting
Neurocenter of Southern Switzerland
Lugano 2659836, Ticino (it) 6900
SwitzerlandSite Not Available
Universitaetsspital Bern - Inselspital
Bern, 43017-3521
SwitzerlandActive - Recruiting
Universitaetsspital Bern - Inselspital
Bern 2661552, 43017-3521
SwitzerlandSite Not Available
Sleep Disorders Center of Alabama
Birmingham, Alabama 35213
United StatesActive - Recruiting
Sleep Disorders Center of Alabama
Birmingham 4049979, Alabama 4829764 35213
United StatesSite Not Available
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
Stanford Center for Sleep Sciences and Medicine
Redwood City 5386834, California 5332921 94063
United StatesSite Not Available
SDS Clinical Trials, Inc.
Santa Ana 5392900, California 5332921 92705
United StatesSite Not Available
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado 80918
United StatesActive - Recruiting
Delta Waves LLC - Hunt - PPDS
Colorado Springs 5417598, Colorado 5417618 80918
United StatesSite Not Available
Florida Pediatric Research Institute
Orlando, Florida 32803
United StatesActive - Recruiting
Florida Pediatric Research Institute
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Neurotrials Research
Atlanta, Georgia 30342
United StatesActive - Recruiting
Georgia Neuro Center
Gainesville, Georgia 30501
United StatesActive - Recruiting
Neurotrials Research
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Georgia Neuro Center
Gainesville 4196586, Georgia 4197000 30501
United StatesSite Not Available
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
Neurocare Inc
Newton 4945283, Massachusetts 6254926 02459
United StatesSite Not Available
Henry Ford Medical Center - Columbus
Novi, Michigan 48377
United StatesActive - Recruiting
Henry Ford Medical Center - Columbus
Novi 5004062, Michigan 5001836 48377
United StatesSite Not Available
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
Research Carolina Elite
Denver 4463523, North Carolina 4482348 28037
United StatesSite Not Available
ARSM Research, LLC
Huntersville 4472370, North Carolina 4482348 28078
United StatesSite Not Available
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
CTI Research Center
Cincinnati 4508722, Ohio 5165418 45212
United StatesSite Not Available
Intrepid Research
Cincinnati 4508722, Ohio 5165418 45227
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Ohio Sleep Medicine Institute
Dublin 5152333, Ohio 5165418 43017
United StatesSite Not Available
Medical University of South Carolina - PPDS
Charleston, South Carolina 29425
United StatesActive - Recruiting
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
United StatesActive - Recruiting
Medical University of South Carolina - PPDS
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Bogan Sleep Consultants, LLC
Columbia 4575352, South Carolina 4597040 29201
United StatesSite Not Available
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
Sleep Therapy and Research Center
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Children's Specialty Group
Norfolk, Virginia 23510
United StatesActive - Recruiting
Children's Specialty Group
Norfolk 4776222, Virginia 6254928 23510
United StatesSite Not Available

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