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Purpose

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. - Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. - Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. - Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) - Participant must have a CGI-S score of ≥ 4 at screening and Day -1 - Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Exclusion Criteria

  • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening - Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. - Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). - Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. - Participant must not have a history of treatment resistance to schizophrenia medications - Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: Xanomeline/Trospium Chloride
    Specified dose on specified days
    Other names:
    • KarXT
    • BMS-986510
Placebo Comparator
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Pillar Clinical Research - Bentonville
Bentonville, Arkansas 72712
Contact:
Fayz Hudefi, Site 0154
479-367-2688

Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
Contact:
Leslie Smith, Site 0139
501-350-3285

Research Centers of America ( Hollywood )
Hollywood, Florida 33024
Contact:
Edwin Gomez, Site 0145
954-604-3900

Atlanta Center for Medical Research
Atlanta, Georgia 30331
Contact:
Elyssa Barron, Site 0166
404-881-5800

Pillar Clinical Research - Richardson
Richardson, Texas 75080
Contact:
Scott Bartley, Site 0133
214-396-4844

More Details

Status
Recruiting
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.