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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
2026-03-31
Completion Date
2030-03-08
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Locations (55)
Local Institution - 0077
Anaheim, California, United States
Local Institution - 0058
Chino, California, United States
Local Institution - 0083
Redlands, California, United States
Local Institution - 0089
San Francisco, California, United States
Local Institution - 0032
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Local Institution - 0103
Lawrenceville, Georgia, United States
Local Institution - 0039
Stone Mountain, Georgia, United States
Local Institution - 0044
Chicago, Illinois, United States
Local Institution - 0105
Evanston, Illinois, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0104
Brookline, Massachusetts, United States
Local Institution - 0059
Worcester, Massachusetts, United States
Local Institution - 0061
Great Neck, New York, United States
Local Institution - 0051
Cincinnati, Ohio, United States
Local Institution - 0097
Philadelphia, Pennsylvania, United States
Local Institution - 0046
Garland, Texas, United States
Local Institution - 0090
McAllen, Texas, United States
Local Institution - 0066
Spring, Texas, United States
Local Institution - 0050
Richmond, Virginia, United States
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
Local Institution - 0073
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, București, 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