A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
NCT ID: NCT07285798
Last Updated: 2026-01-05
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
2029-08-04
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 - 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 - 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 - 0014
Fort Worth, Texas, 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 - 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 - 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
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 0062
Role: primary
Site 0013
Role: primary
Site 0117
Role: primary
Site 0126
Role: primary
Site 0115
Role: primary
Site 0116
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Site 0080
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Site 0006
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Site 0051
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Site 0016
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Site 0046
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Site 0114
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Site 0038
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Site 0052
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Site 0003
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Site 0014
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Site 0009
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Site 0019
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Site 0102
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Site 0088
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Site 0089
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Site 0103
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Site 0111
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Site 0112
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Site 0110
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Site 0096
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Site 0101
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Site 0097
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Site 0094
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Site 0090
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Site 0095
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Site 0091
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Site 0092
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Site 0093
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Site 0108
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Site 0105
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Site 0109
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Site 0107
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Site 0106
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Site 0113
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Site 0104
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Site 0118
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Site 0120
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Site 0124
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Site 0123
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Site 0121
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Site 0119
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Site 0122
Role: primary
Site 0085
Role: primary
Site 0087
Role: primary
Site 0084
Role: primary
Site 0086
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0045
Identifier Type: -
Identifier Source: org_study_id
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