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A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively
Official title: A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-04-07
Completion Date
2030-03-08
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Locations (95)
Local Institution - 0054
Dothan, Alabama, United States
Local Institution - 0163
Phoenix, Arizona, United States
Advanced Research Center Inc.
Anaheim, California, United States
Local Institution - 0159
Anaheim, California, United States
Inland Psychiatric Medical Group.
Chino, California, United States
Proscience Research Group
Culver City, California, United States
Local Institution - 0162
Glendale, California, United States
Local Institution - 0153
Los Angeles, California, United States
Local Institution - 0158
Orange, California, United States
Local Institution - 0174
San Diego, California, United States
Local Institution - 0089
San Francisco, California, United States
Local Institution - 0157
San Rafael, California, United States
Local Institution - 0161
Colorado Springs, Colorado, United States
Local Institution - 0154
New Haven, Connecticut, United States
Local Institution - 0145
Boca Raton, Florida, United States
Local Institution - 0160
Gainesville, Florida, United States
Local Institution - 0164
Gainesville, Florida, United States
Local Institution - 0168
Hollywood, Florida, United States
Apg Research, Llc
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Salveo Integrative Health - Lawrenceville
Lawrenceville, Georgia, United States
Denali Health Atlanta, LLC
Stone Mountain, Georgia, United States
Local Institution - 0175
Chicago, Illinois, United States
EmVenio Research Center - Prime Healthcare
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Local Institution - 0132
Lexington, Massachusetts, United States
Local Institution - 0059
Worcester, Massachusetts, United States
Local Institution - 0152
Bloomfield Hills, Michigan, United States
Local Institution - 0142
Columbia, Missouri, United States
Local Institution - 0147
Lincoln, Nebraska, United States
Local Institution - 0144
Las Vegas, Nevada, United States
Local Institution - 0146
Neptune City, New Jersey, United States
Local Institution - 0061
Great Neck, New York, United States
Local Institution - 0156
Staten Island, New York, United States
Local Institution - 0151
The Bronx, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Local Institution - 0148
Cincinnati, Ohio, United States
Local Institution - 0139
West Chester, Ohio, United States
Local Institution - 0143
Danville, Pennsylvania, United States
Local Institution - 0150
Pittsburgh, Pennsylvania, United States
Local Institution - 0137
Nashville, Tennessee, United States
Local Institution - 0149
Dallas, Texas, United States
VAST Clinical Research
Garland, Texas, United States
Local Institution - 0169
Houston, Texas, United States
Local Institution - 0165
Plano, Texas, United States
Local Institution - 0176
Plano, Texas, United States
Local Institution - 0066
Spring, Texas, United States
Local Institution - 0141
Orem, Utah, United States
Local Institution - 0167
West Point, Utah, United States
Local Institution - 0050
Richmond, Virginia, United States
Local Institution - 0155
Everett, Washington, United States
Local Institution - 0084
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0085
La Plata, Buenos Aires, Argentina
Local Institution - 0036
Buenos Aires, Argentina
Local Institution - 0035
Córdoba, Argentina
Local Institution - 0116
Santiago del Estero, Argentina
Local Institution - 0107
Westmead, New South Wales, Australia
Local Institution - 0106
Brisbane, Queensland, Australia
Local Institution - 0108
Melbourne, Victoria, Australia
Local Institution - 0109
Melbourne, Victoria, Australia
Local Institution - 0111
Edmonton, Alberta, Canada
Local Institution - 0110
Kingston, Ontario, Canada
Local Institution - 0113
Toronto, Ontario, Canada
Local Institution - 0112
Montreal, Quebec, Canada
Local Institution - 0118
Bordeaux, France
Local Institution - 0120
Bron, France
Local Institution - 0119
Paris, France
Local Institution - 0121
Gdansk, Germany
Local Institution - 0129
Budapest, Hungary
Local Institution - 0130
Gyula, Hungary
Local Institution - 0131
Szeged, Hungary
Local Institution - 0075
Chikugo, Fukuoka, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0025
Zentsujichó, Kagawa-ken, Japan
Local Institution - 0062
Miyakonojō, Miyazaki, Japan
Local Institution - 0086
Bunkyo-ku, Tokyo, Japan
Local Institution - 0056
Ōta-ku, Tokyo, Japan
Local Institution - 0063
Yokohama, Kanagawa, Japan
Local Institution - 0128
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0125
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0127
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0126
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0123
Szczecin, West Pomeranian Voivodeship, Poland
Local Institution - 0124
Katowice, Poland
Local Institution - 0122
Lublin, Poland
Local Institution - 0029
Bucharest, Bucharest, Romania
Local Institution - 0040
Bucharest, Romania
Cabinet Medical Individual Dr Gheorghita Karina Lidia
Bucharest, Romania
Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry
Cluj-Napoca, Romania
Local Institution - 0008
Iași, Romania
Emergency Clinical Hospital For Children Louis Turcanu Timis
Timișoara, Romania
Local Institution - 0101
Barcelona, Spain
Local Institution - 0099
Barcelona, Spain
Local Institution - 0098
Madrid, Spain
Local Institution - 0100
Madrid, Spain