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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

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

Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
Contact:
Leslie Smith, Site 0017
501-350-3285

Clinical Innovations, Inc. dba CITrials
Bellflower, California 90706
Contact:
Robert Bota, Site 0007
562-748-4999

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

ATP Clinical Research
Orange, California 92866
Contact:
Gustavo Alva, Site 0016
949-354-5353

Innovative Clinical Research
Lauderhill, Florida 33319
Contact:
Rishi Kakar, Site 0003
786-512-4106

Health Synergy Clinical Research
West Palm Beach, Florida 33407
Contact:
Mohammad Nisar, Site 0004
786-831-7303

Uptown Research Institute
Chicago, Illinois 60640
Contact:
John Sonnenberg, Site 0005
773-968-9868

IMA Clinical Research Las Vegas
Las Vegas, Nevada 89102
Contact:
Mustafa Rawaf, Site 0013
702-527-7401

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

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

InSite Clinical Research
DeSoto, Texas 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

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.