A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07284745
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Irritability Associated With Autism Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Key Dates

Start date
Sep 11, 2026
Status verified
Mar 2026
Primary completion
Jul 5, 2029
Completion
Jul 5, 2029

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT + KarX-EC Arm
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [ Time Frame: Week 8 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (27)

FacilityCityStateZIPSite coordinators
Local Institution - 0036DothanAlabama36303
Site 0036
Local Institution - 0236PhoenixArizona85006
Site 0236
Local Institution - 0031AnaheimCalifornia92805
Site 0031
Local Institution - 0092ChinoCalifornia91710-
Local Institution - 0257GlendaleCalifornia91203
Site 0257
Local Institution - 0181San RafaelCalifornia94903
Site 0181
Local Institution - 0252Colorado SpringsColorado80910
Site 0252
Local Institution - 0256HartfordConnecticut06106
Site 0256
Local Institution - 0264Boca RatonFlorida33428
Site 0264
Local Institution - 0099GainesvilleFlorida32607
Site 0099
Local Institution - 0278GainesvilleFlorida32607
Site 0278
Local Institution - 0155Peachtree CornersGeorgia30071
Site 0155
Local Institution - 0266ChicagoIllinois60622
Site 0266
Local Institution - 0160Bloomfield HillsMichigan48302
Site 0160
Local Institution - 0220DetroitMichigan48203
Site 0220
Local Institution - 0110Las VegasNevada89128
Site 0110
Local Institution - 0246Staten IslandNew York10312
Site 0246
Local Institution - 0263The BronxNew York10461
Site 0263
Local Institution - 0247West ChesterOhio45069
Site 0247
Local Institution - 0269DanvillePennsylvania17821
Site 0269
Local Institution - 0105PittsburghPennsylvania15213
Site 0105
Local Institution - 0041DallasTexas75243
Site 0041
Local Institution - 0273Fort WorthTexas76104
Site 0273
Local Institution - 0185SpringTexas77381
Site 0185
Local Institution - 0074BountifulUtah84010
Site 0074
Local Institution - 0271ProvoUtah84604
Site 0271
Local Institution - 0260RichmondVirginia23298-0341
Site 0260

Find similar trials in Dothan, AL

By research site
Local Institution - 0036· Dothan, ALLocal Institution - 0236· Phoenix, AZLocal Institution - 0031· Anaheim, CALocal Institution - 0092· Chino, CALocal Institution - 0257· Glendale, CALocal Institution - 0181· San Rafael, CA

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