A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
NCT ID: NCT07284745
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
176 participants
INTERVENTIONAL
2026-02-27
2026-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KarXT + KarX-EC Arm
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have ABC-I ≥18 (C18 on the Irritability subscale of the ABC-I) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
Exclusion Criteria
* Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
* Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
5 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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 - 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 - 0266
Fort Worth, 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
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0036
Role: primary
Site 0236
Role: primary
Site 0031
Role: primary
Site 0092
Role: primary
Site 0257
Role: primary
Site 0181
Role: primary
Site 0252
Role: primary
Site 0256
Role: primary
Site 0264
Role: primary
Site 0099
Role: primary
Site 0278
Role: primary
Site 0155
Role: primary
Site 0160
Role: primary
Site 0220
Role: primary
Site 0110
Role: primary
Site 0246
Role: primary
Site 0263
Role: primary
Site 0247
Role: primary
Site 0269
Role: primary
Site 0105
Role: primary
Site 0041
Role: primary
Site 0266
Role: primary
Site 0273
Role: primary
Site 0185
Role: primary
Site 0074
Role: primary
Site 0271
Role: primary
Site 0260
Role: primary
Site 0046
Role: primary
Site 0048
Role: primary
Site 0047
Role: primary
Site 0288
Role: primary
Site 0049
Role: primary
Site 0140
Role: primary
Site 0010
Role: primary
Site 0007
Role: primary
Site 0045
Role: primary
Site 0286
Role: primary
Site 0136
Role: primary
Site 0134
Role: primary
Site 0135
Role: primary
Site 0205
Role: primary
Site 0187
Role: primary
Site 0056
Role: primary
Site 0061
Role: primary
Site 0218
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0044
Identifier Type: -
Identifier Source: org_study_id
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