A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Purpose

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Condition

  • Bipolar-I Disorder With Mania or Mania With Mixed Features

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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. - Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. - 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
    • Trospium Chloride
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

Pillar Clinical Research - Bentonville
Bentonville, Arkansas 72712
Contact:
Fayz Hudefi, Site 0058
479-367-2688

Woodland International Research Group
Little Rock, Arkansas 72211
Contact:
George Konis, Site 0011
501-221-8681

Advanced Research Center Inc.
Anaheim, California 92805
Contact:
Steven Macina, Site 0005
714-999-6688

CITrials
Bellflower, California 90706
Contact:
Robert Bota, Site 0008
562-748-4999

Collaborative Neuroscience Research, LLC
Long Beach, California 90806
Contact:
David Walling, Site 0059
714-799-7799

Catalina Research Institute, LLC
Montclair, California 91763
Contact:
Stephen Volk, Site 0072
909-590-8409

NRC Research Institute
Orange, California 92868
Contact:
Tony Ortiz, Site 0053
714-289-1100

Connecticut Mental Health Center
New Haven, Connecticut 06519
Contact:
Deepak D'Souza, Site 0124
20393257112594

Research Centers of America ( Hollywood )
Hollywood, Florida 33024
Contact:
Edwin Gomez, Site 0043
954-604-3900

Advanced Research Institute of Miami
Homestead, Florida 33033
Contact:
Moraima Trujillo, Site 0020
305-246-0001

Innovative Clinical Research, Inc.
Miami Lakes, Florida 33016
Contact:
Rishi Kakar, Site 0054
786-512-4106

South Florida Research Phase I-IV
Miami Springs, Florida 33166
Contact:
Silvia Silva Duluc, Site 0069
305-669-6166

Health Synergy Clinical Research
West Palm Beach, Florida 33407
Contact:
Mohammad Nisar, Site 0023
786-831-7303

Synexus Clinical Research US, Inc.
Atlanta, Georgia 30328
Contact:
Bethany Davis, Site 0009
404-255-6005

CenExel iResearch, LLC
Savannah, Georgia 31405
Contact:
Michael Mobley, Site 0057
912-744-0800

Pillar Clinical Research -Chicago
Chicago, Illinois 60641
Contact:
Roueen Rafeyan, Site 0047
312-865-6336

Richmond Behavioral Associates
Staten Island, New York 10314
Contact:
Peter Weiden, Site 0030
917-701-7484

Neuro-Behavioral Clinical Research
North Canton, Ohio 44720
Contact:
Shishuka Malhotra, Site 0013
330-493-1118

Pillar Clinical Research - Richardson
Richardson, Texas 75080
Contact:
Scott Bartley, Site 0044
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

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects 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.