Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of 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
176
Start Date
2026-09-11
Completion Date
2029-08-04
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Locations (55)
Local Institution - 0062
Phoenix, Arizona, United States
Local Institution - 0001
Bentonville, Arkansas, United States
Local Institution - 0013
Glendale, California, United States
Local Institution - 0117
Los Angeles, California, United States
Local Institution - 0126
Orange, California, United States
Local Institution - 0115
San Juan Capistrano, California, United States
Local Institution - 0116
San Rafael, California, United States
Local Institution - 0080
Orlando, Florida, United States
Local Institution - 0014
Chicago, Illinois, United States
Local Institution - 0006
Lexington, Kentucky, United States
Local Institution - 0051
Lexington, Massachusetts, United States
Local Institution - 0016
Columbia, Missouri, United States
Local Institution - 0046
Lincoln, Nebraska, United States
Local Institution - 0114
Neptune City, New Jersey, United States
Local Institution - 0038
Staten Island, New York, United States
Local Institution - 0052
Cincinnati, Ohio, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, United States
Local Institution - 0009
Orem, Utah, United States
Local Institution - 0019
Everett, Washington, United States
Local Institution - 0102
Bron, France
Local Institution - 0088
Eysines, France
Local Institution - 0089
Paris, France
Local Institution - 0103
Gdansk, Germany
Local Institution - 0111
Budapest, Hungary
Local Institution - 0127
Budapest, Hungary
Local Institution - 0112
Siófok, Hungary
Local Institution - 0110
Szeged, Hungary
Local Institution - 0096
Kozhikode, Kerala, India
Local Institution - 0101
Sakri, Maharashtra, India
Local Institution - 0097
Kolkata, West Bengal, India
Local Institution - 0094
Miyakonojō, Miyazaki, Japan
Local Institution - 0090
Hirakata, Osaka, Japan
Local Institution - 0095
Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan
Local Institution - 0091
Ōta-ku, Tokyo, Japan
Local Institution - 0092
Saga, Japan
Local Institution - 0093
Yokohama, Kanagawa, Japan
Local Institution - 0108
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0105
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0109
Kraśnik, Lublin Voivodeship, Poland
Local Institution - 0107
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0106
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0113
Szczecin, West Pomeranian Voivodeship, Poland
Local Institution - 0129
Szczecin, West Pomeranian Voivodeship, Poland
Local Institution - 0104
Katowice, Poland
Local Institution - 0118
Bucharest, București, Romania
Local Institution - 0120
Bucharest, București, Romania
Local Institution - 0124
Bucharest, Romania
Local Institution - 0123
Cluj-Napoca, Romania
Local Institution - 0121
Iași, Romania
Local Institution - 0119
Sibiu, Romania
Local Institution - 0122
Timișoara, Romania
Local Institution - 0085
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0087
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0084
Madrid, Spain
Local Institution - 0086
Madrid, Spain