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A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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
2029-07-05
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 (45)
Local Institution - 0036
Dothan, Alabama, United States
Local Institution - 0236
Phoenix, Arizona, United States
Local Institution - 0031
Anaheim, California, United States
Local Institution - 0092
Chino, California, United States
Local Institution - 0257
Glendale, California, United States
Local Institution - 0181
San Rafael, California, United States
Local Institution - 0252
Colorado Springs, Colorado, United States
Local Institution - 0256
Hartford, Connecticut, United States
Local Institution - 0264
Boca Raton, Florida, United States
Local Institution - 0099
Gainesville, Florida, United States
Local Institution - 0278
Gainesville, Florida, United States
Local Institution - 0155
Peachtree Corners, Georgia, United States
Local Institution - 0266
Chicago, Illinois, United States
Local Institution - 0160
Bloomfield Hills, Michigan, United States
Local Institution - 0220
Detroit, Michigan, United States
Local Institution - 0110
Las Vegas, Nevada, United States
Local Institution - 0246
Staten Island, New York, United States
Local Institution - 0263
The Bronx, New York, United States
Local Institution - 0247
West Chester, Ohio, United States
Local Institution - 0269
Danville, Pennsylvania, United States
Local Institution - 0105
Pittsburgh, Pennsylvania, United States
Local Institution - 0041
Dallas, Texas, United States
Local Institution - 0273
Fort Worth, Texas, United States
Local Institution - 0185
Spring, Texas, United States
Local Institution - 0074
Bountiful, Utah, United States
Local Institution - 0271
Provo, Utah, United States
Local Institution - 0260
Richmond, Virginia, United States
Local Institution - 0046
La Plata, Buenos Aires, Argentina
Local Institution - 0048
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0047
Córdoba, Argentina
Local Institution - 0288
Córdoba, Argentina
Local Institution - 0049
Mendoza, Argentina
Local Institution - 0140
Santiago del Estero, Argentina
Local Institution - 0010
Westmead, New South Wales, Australia
Local Institution - 0007
Brisbane, Queensland, Australia
Local Institution - 0045
Melbourne, Victoria, Australia
Local Institution - 0286
Melbourne, Victoria, Australia
Local Institution - 0136
Edmonton, Alberta, Canada
Local Institution - 0134
Hamilton, Ontario, Canada
Local Institution - 0135
Kingston, Ontario, Canada
Local Institution - 0205
Toronto, Ontario, Canada
Local Institution - 0187
Montreal, Quebec, Canada
Local Institution - 0056
Kozhikode, Kerala, India
Local Institution - 0061
Nagpur, Maharashtra, India
Local Institution - 0218
Kolkata, West Bengal, India