A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT07424404
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • KarXT — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Key Dates

First listed
Feb 20, 2026
Start date
Apr 7, 2026
Status verified
Aug 2026
Primary completion
Mar 8, 2030
Completion
Mar 8, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of KarXT for Schizophrenia
  • Experimental: Administration of KarXT for Autism-related Irritability

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 54 weeks ]

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 (51)

FacilityCityStateZIPSite coordinators
Local Institution - 0054DothanAlabama36303
Site 0054
Local Institution - 0163PhoenixArizona85006
Site 0163
Advanced Research Center Inc.AnaheimCalifornia92805
Steven Macina, Site 0077
714-999-6688
Local Institution - 0159AnaheimCalifornia92805
Site 0159
Inland Psychiatric Medical Group.ChinoCalifornia91710
Nandita Puchakayala, Site 0058
909-488-9116
Proscience Research GroupCulver CityCalifornia90230
Marina Bussel, Site 0024
424-227-8127
Local Institution - 0162GlendaleCalifornia91203
Site 0162
Local Institution - 0153Los AngelesCalifornia90095
Site 0153
Local Institution - 0158OrangeCalifornia92868
Site 0158
Local Institution - 0174San DiegoCalifornia92102
Site 0174
Local Institution - 0089San FranciscoCalifornia94158
Site 0089
Local Institution - 0157San RafaelCalifornia94903
Site 0157
Local Institution - 0161Colorado SpringsColorado80910
Site 0161
Local Institution - 0154New HavenConnecticut06520
Site 0154
Local Institution - 0145Boca RatonFlorida33428
Site 0145
Local Institution - 0160GainesvilleFlorida32607
Site 0160
Local Institution - 0164GainesvilleFlorida32607
Site 0164
Local Institution - 0168HollywoodFlorida33024
Site 0168
Apg Research, LlcOrlandoFlorida32803
Morteza Nadjafi, Site 0032
407-423-7149
Atlanta Center for Medical ResearchAtlantaGeorgia30331
Elyssa Barron, Site 0057
404-881-5800
Salveo Integrative Health - LawrencevilleLawrencevilleGeorgia30046
Shahzad Hashmi, Site 0103
Denali Health Atlanta, LLCStone MountainGeorgia30083
Maria Johnson, Site 0039
EmVenio Research Center - Prime HealthcareChicagoIllinois60622
Mitchell Glaser, Site 0044
773-620-2995
Local Institution - 0175ChicagoIllinois60611
Site 0175
Boston Children's HospitalBostonMassachusetts02445
Joseph Gonzalez-Heydrich, Site 0076
Local Institution - 0132LexingtonMassachusetts02421
Site 0132
Local Institution - 0059WorcesterMassachusetts01608
Site 0059
Local Institution - 0152Bloomfield HillsMichigan48302
Site 0152
Local Institution - 0142ColumbiaMissouri65201
Site 0142
Local Institution - 0147LincolnNebraska68526
Site 0147
Local Institution - 0144Las VegasNevada89128
Site 0144
Local Institution - 0146Neptune CityNew Jersey07753-4859
Site 0146
Local Institution - 0061Great NeckNew York11021
Site 0061
Local Institution - 0156Staten IslandNew York10314
Site 0156
Local Institution - 0151The BronxNew York10461
Site 0151
Local Institution - 0148CincinnatiOhio45229
Site 0148
University of Cincinnati Cancer InstituteCincinnatiOhio45219
Melissa DelBello, Site 0051
Local Institution - 0139West ChesterOhio45069-
Local Institution - 0143DanvillePennsylvania17821
Site 0143
Local Institution - 0150PittsburghPennsylvania15213-3403
Site 0150
Local Institution - 0137NashvilleTennessee37212
Site 0137
Local Institution - 0149DallasTexas75243
Site 0149
VAST Clinical ResearchGarlandTexas75043
Asikaiwe Chima, Site 0046
Local Institution - 0169HoustonTexas77043
Site 0169
Local Institution - 0165PlanoTexas75093
Site 0165
Local Institution - 0176PlanoTexas75093
Site 0176
Local Institution - 0066SpringTexas77381
Site 0066
Local Institution - 0141OremUtah84097
Site 0141
Local Institution - 0167West PointUtah84015
Site 0167
Local Institution - 0050RichmondVirginia23284
Site 0050
Local Institution - 0155EverettWashington98201
Site 0155

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PsychiatryMental healthBehavioral health
By research site
Local Institution - 0054· Dothan, ALLocal Institution - 0163· Phoenix, AZAdvanced Research Center Inc.· Anaheim, CALocal Institution - 0159· Anaheim, CAInland Psychiatric Medical Group.· Chino, CAProscience Research Group· Culver City, CA

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