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

NCT06951698 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: CN012-00362024-520165-32U1111-1316-7438
• Study Type: interventional
• Target: 274
• Locations: 8 countries
• Sites: 63

Brief Summary

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

Conditions

Bipolar-I Disorder With Mania or Mania With Mixed Features

Keywords

Bipolar-I; Mania; Mixed

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Young Mania Rating Scale (YMRS) score

  The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.

  At week 3

Secondary Outcomes (3)

• Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)

  At week 3

• Occurrence of response based on a ≥ 50% decrease from baseline in YMRS total score

  At week 3

• Occurrence of response based on CGI-BP change from baseline ≥ 1

  At week 3

Study Arms (2)

KarXT

EXPERIMENTAL

Flexible dosing

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Specified dose on specified days

Placebo

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline, Trospium Chloride

KarXT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (63)

Pillar Clinical Research - Bentonville

Bentonville, Arkansas, 72712, United States

RECRUITING

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

RECRUITING

Advanced Research Center Inc.

Anaheim, California, 92805, United States

RECRUITING

CITrials

Bellflower, California, 90706, United States

RECRUITING

Local Institution - 0014

Cerritos, California, 90703, United States

NOT YET RECRUITING

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

RECRUITING

Catalina Research Institute, LLC

Montclair, California, 91763, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

RECRUITING

Advanced Research Institute of Miami

Homestead, Florida, 33033, United States

RECRUITING

South Florida Research Phase I-IV

Miami, Florida, 33166, United States

RECRUITING

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

RECRUITING

Local Institution - 0015

Miami Lakes, Florida, 33016, United States

NOT YET RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

Synexus Clinical Research US, Inc.

Atlanta, Georgia, 30328, United States

RECRUITING

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

RECRUITING

Pillar Clinical Research -Chicago

Chicago, Illinois, 60641, United States

RECRUITING

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

RECRUITING

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

RECRUITING

Local Institution - 0029

Irving, Texas, 75062, United States

WITHDRAWN

Pillar Clinical Research - Richardson

Richardson, Texas, 75080, United States

RECRUITING

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

Sanatorio Morra S.A.

Córdoba, 5000, Argentina

RECRUITING

Local Institution - 0108

Mendoza, 5502, Argentina

NOT YET RECRUITING

Local Institution - 0109

Mendoza, 5502, Argentina

NOT YET RECRUITING

Ramsay Clinic Northside

St Leonards, New South Wales, 2065, Australia

RECRUITING

Ramsay Clinic New Farm

Brisbane, Queensland, 4005, Australia

RECRUITING

Center for Mental Health Prof. Dr. Ivan Temkov

Burgas, 8001, Bulgaria

RECRUITING

State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

Novi Iskar, 1282, Bulgaria

RECRUITING

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

Pleven, 5800, Bulgaria

RECRUITING

MHAT "Dr. Ival Seliminski"

Sliven, 8800, Bulgaria

RECRUITING

Mental Health Center - Vratsa

Vratsa, 3000, Bulgaria

RECRUITING

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, 9024, Hungary

RECRUITING

Local Institution - 0114

Budapest, 0, Hungary

NOT YET RECRUITING

Semmelweis Egyetem

Budapest, 1083, Hungary

RECRUITING

Hotei Hospital

Kōnan, Aichi-ken, 4838248, Japan

RECRUITING

Okehazama Hospital

Toyoake, Aichi-ken, 470-1168, Japan

RECRUITING

National Kohnodai Medical Center.

Ichikawa, Chiba, 272-8516, Japan

RECRUITING

Local Institution - 0100

Kitakyushu, Fukuoka, 803-0831, Japan

WITHDRAWN

Obihiro Kosei Hospital

Obihiro, Hokkaido, 080-0024, Japan

RECRUITING

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, 002-8029, Japan

RECRUITING

Kansai Medical University Medical Center

Moriguchi, Osaka, 570-8507, Japan

RECRUITING

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, 847-0031, Japan

RECRUITING

Local Institution - 0081

Iruma, Saitama, 350-0495, Japan

WITHDRAWN

Saitama Konan Hospital

Kumagaya, Saitama, 360-0114, Japan

RECRUITING

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

RECRUITING

Narimasu Kosei Hospital

tabashi City, Tokyo, 175-0091, Japan

RECRUITING

Kuramitsu Hospital

Fukuoka, 819-0037, Japan

RECRUITING

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, 880-8510, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

RECRUITING

Local Institution - 0084

Osaka, 590-0018, Japan

NOT YET RECRUITING

Showa Medical University Karasuyama Hospital

Tokyo, 157-8577, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, 641-8510, Japan

RECRUITING

Yamagata Sakuracho Hospital

Yamagata, 990-0045, Japan

RECRUITING

North Shore Hospital

Auckland, 0622, New Zealand

RECRUITING

Centrum Medyczne HCP

Poznan, Greater Poland Voivodeship, 61-485, Poland

RECRUITING

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, 02-957, Poland

RECRUITING

Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku

Bialystok, Podlaskie Voivodeship, 15-272, Poland

RECRUITING

Local Institution - 0111

Gdansk, Pomeranian Voivodeship, 80-214, Poland

NOT YET RECRUITING

M2M Med

Rybnik, Silesian Voivodeship, 44-200, Poland

RECRUITING

Local Institution - 0102

Sosnowiec, Silesian Voivodeship, 41-200, Poland

NOT YET RECRUITING

Clinica Inventiva

Tuszyn, 95-080, Poland

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Mania

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

NZ (1); AR (4); BU (5); US (22); JP (19); AU (2); PL (7); HU (3)