A Study to Evaluate the Effect of KarXT on Urological Safety

Purpose

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Condition

  • Schizophrenia

Eligibility

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

Inclusion Criteria

  • Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2). - Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2. - Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.

Exclusion Criteria

  • Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results. - Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study. - Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: Xanomeline/trospium chloride
    Specified dose on specified days
    Other names:
    • KarXT
    • BMS-986510

Recruiting Locations

CenExel CNS - Garden Grove
Garden Grove 5351515, California 5332921 92845
Contact:
David Walling, Site 0006
714-799-7799

Hassman Research Institute Marlton Site
Marlton 4502911, New Jersey 5101760 08053
Contact:
Elan Cohen, Site 0002
267-981-8911

Adams Clinical Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Cassie Blanchard, Site 0014
631-252-0769

InSite Clinical Research
DeSoto 4685524, Texas 4736286 75115
Contact:
Benji Kurian, Site 0015
214-497-3151

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

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