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 Anaheim, California.

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

Start date
Apr 7, 2026
Status verified
May 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 (19)

FacilityCityStateZIPSite coordinators
Local Institution - 0077AnaheimCalifornia92805
Site 0077
Local Institution - 0058ChinoCalifornia91710
Site 0058
Local Institution - 0024Culver CityCalifornia90230
Site 0024
Local Institution - 0083RedlandsCalifornia92373
Site 0083
Local Institution - 0089San FranciscoCalifornia94158
Site 0089
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
Local Institution - 0039Stone MountainGeorgia30083
Site 0039
EmVenio Research Center - Prime HealthcareChicagoIllinois60622
Mitchell Glaser, Site 0044
773-620-2995
Local Institution - 0076BostonMassachusetts02115
Site 0076
Local Institution - 0059WorcesterMassachusetts01608
Site 0059
Local Institution - 0061Great NeckNew York11021
Site 0061
University of Cincinnati Cancer InstituteCincinnatiOhio45219
Melissa DelBello, Site 0051
Local Institution - 0097PhiladelphiaPennsylvania19139
Site 0097
Local Institution - 0137NashvilleTennessee37212
Site 0137
Local Institution - 0046GarlandTexas75043
Site 0046
Local Institution - 0066SpringTexas77381
Site 0066
Local Institution - 0050RichmondVirginia23284
Site 0050

Find similar trials in Anaheim, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Local Institution - 0077· Anaheim, CALocal Institution - 0058· Chino, CALocal Institution - 0024· Culver City, CALocal Institution - 0083· Redlands, CALocal Institution - 0089· San Francisco, CAApg Research, Llc· Orlando, FL

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