Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

Purpose

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

Condition

  • Schizophrenia

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