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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
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Locations (58)
Advanced Research Center Inc.
Anaheim, California, United States
Inland Psychiatric Medical Group.
Chino, California, United States
Local Institution - 0024
Culver City, California, United States
Local Institution - 0083
Redlands, California, United States
Local Institution - 0089
San Francisco, California, 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
EmVenio Research Center - Prime Healthcare
Chicago, Illinois, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0059
Worcester, Massachusetts, United States
Local Institution - 0061
Great Neck, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Local Institution - 0137
Nashville, Tennessee, United States
Local Institution - 0046
Garland, Texas, United States
Local Institution - 0066
Spring, Texas, United States
Local Institution - 0050
Richmond, Virginia, 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 - 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 - 0122
Kraśnik, Lublin 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 - 0029
Bucharest, Bucharest, Romania
Local Institution - 0031
Cluj-Napoca, Cluj, Romania
Local Institution - 0040
Bucharest, Romania
Local Institution - 0042
Bucharest, Romania
Local Institution - 0008
Iași, Romania
Local Institution - 0038
Timișoara, Romania
Local Institution - 0101
Barcelona, Spain
Local Institution - 0099
Barcelona, Spain
Local Institution - 0098
Madrid, Spain
Local Institution - 0100
Madrid, Spain