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Purpose

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Condition

Eligibility

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

Inclusion Criteria

  • Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation. - Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks). - Participants must require hospitalization for the acute exacerbation or relapse of mania. - Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug. - Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline. - Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

Exclusion Criteria

  • Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. - Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year). - Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test. - Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS). - Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results. - 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
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT 		Flexible dosing
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
    • Xanomeline and trospium chloride
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
Contact:
Leslie Smith, Site 0014
501-350-3285

Woodland Research Northwest
Rogers, Arkansas 72758
Contact:
Robert Billingsley, Site 0025
479-927-3000

Proscience Research Group
Culver City, California 90230
Contact:
Marina Bussel, Site 0021
424-227-8127

Clinical Innovations, Inc. dba CITrials
Riverside, California 92506
Contact:
Evagelos Coskinas, Site 0018
951300492

Collaborative Neuroscience Research, LLC
Torrance, California 90502
Contact:
Lara Shirikjian, Site 0074
310-523-4200

Behavioral Clinical Research
Hollywood, Florida 33021
Contact:
Olga Lapeyra, Site 0032
954-375-7794

LCC Medical Research Institute
Miami, Florida 33126
Contact:
Yesenia Kuan, Site 0026
305-400-0814

Innovative Clinical Research, Inc.
Miami Lakes, Florida 33016
Contact:
Rishi Kakar, Site 0081
786-512-4106

South Florida Research Phase I-IV
Miami Springs, Florida 33166
Contact:
Silvia Silva Duluc, Site 0015
305-669-6166

Health Synergy Clinical Research
West Palm Beach, Florida 33407
Contact:
Mohammad Nisar, Site 0083
786-831-7303

Atlanta Center for Medical Research
Atlanta, Georgia 30331
Contact:
Elyssa Barron, Site 0022
404-881-5800

CenExel iResearch, LLC
Decatur, Georgia 30030
Contact:
Kimball Johnson, Site 0016
404-537-1281

CBH Health
Gaithersburg, Maryland 20877
Contact:
Elia Acevedo Diaz, Site 0024
301-251-4702

Precise Research Centers
Flowood, Mississippi 39232
Contact:
Joseph Kwentus, Site 0017
601-420-5810

Arch Clinical Trials
St Louis, Missouri 63141
Contact:
Junaid Syed, Site 0023
314-771-6387

Hassman Research Institute Marlton Site
Marlton, New Jersey 08053
Contact:
Elan Cohen, Site 0080
267-981-8911

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Caleb Adler, Site 0029
513-404-0279

Neuro-Behavioral Clinical Research
North Canton, Ohio 44720
Contact:
Shishuka Malhotra, Site 0038
330-493-1118

InSite Clinical Research
DeSoto, Texas 75115
Contact:
Rajinder Shiwach, Site 0012
972-283-6286

Pillar Clinical Research - Richardson
Richardson, Texas 75080
Contact:
Scott Bartley, Site 0037
214-396-4844

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.