NCT06951711|RecruitingPhase 3FDA Drug

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CN012-00372024-520195-94U1111-1316-7466

Study Type

interventional

Target

274

Locations

10 countries

Sites

Timeline

RegisteredApr 2025

StartedJun 2025

CompletionNov 2026

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

274

participants targeted

Target at P50-P75 for phase_3

Timeline

5mo left

Started Jun 2025

Geographic Reach

10 countries

78 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Progress72%

Jun 2025Nov 2026

First Submitted

Initial submission to the registry

April 23, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2026

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

April 23, 2025

Last Update Submit

June 3, 2026

Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed Features

Keywords

Bipolar-I disorderManiaBipolar-I disorder with Mania

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 ≥ 50% decrease from baseline in YMRS score or total score
At week 3
Occurrence of response based on change from baseline ≥ 1 in CGI-BP
At week 3

Study Arms (2)

KarXT

EXPERIMENTAL

Flexible dosing

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KarXTDRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline and trospium chloride

KarXT

PlaceboOTHER

Specified dose on specified days

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bristol-Myers Squibblead

Study Sites (78)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, 72204, United States

RECRUITING

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

RECRUITING

Proscience Research Group

Culver City, California, 90230, United States

RECRUITING

Clinical Innovations, Inc. dba CITrials

Riverside, California, 92506, United States

RECRUITING

Collaborative Neuroscience Research, LLC

Torrance, California, 90502, United States

RECRUITING

Local Institution - 0036

Hialeah Gardens, Florida, 33016, United States

WITHDRAWN

Behavioral Clinical Research

Hollywood, Florida, 33021, United States

RECRUITING

LCC Medical Research Institute

Miami, Florida, 33126, United States

RECRUITING

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

RECRUITING

South Florida Research Phase I-IV

Miami Springs, Florida, 33166, United States

RECRUITING

Local Institution - 0019

Tampa, Florida, 33618, United States

WITHDRAWN

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

Local Institution - 0020

Chicago, Illinois, 60640, United States

NOT YET RECRUITING

CBH Health

Gaithersburg, Maryland, 20877, United States

RECRUITING

Precise Research Centers

Flowood, Mississippi, 39232, United States

RECRUITING

Arch Clinical Trials

St Louis, Missouri, 63141, United States

RECRUITING

Local Institution - 0076

North Las Vegas, Nevada, 89030, United States

WITHDRAWN

Hassman Research Institute Marlton Site

Marlton, New Jersey, 08053, United States

RECRUITING

Local Institution - 0031

Marlton, New Jersey, 08053, United States

WITHDRAWN

Local Institution - 0075

Charlotte, North Carolina, 28211, United States

WITHDRAWN

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Neuro-Behavioral Clinical Research

North Canton, Ohio, 44720, United States

RECRUITING

InSite Clinical Research

DeSoto, Texas, 75115, United States

RECRUITING

Local Institution - 0028

Houston, Texas, 77021, United States

WITHDRAWN

Local Institution - 0095

Richardson, Texas, 75080, United States

NOT YET RECRUITING

Pillar Clinical Research - Richardson

Richardson, Texas, 75080, United States

RECRUITING

Local Institution - 0009

Zagreb, City of Zagreb, 10090, Croatia

WITHDRAWN

Klinika za psihijatriju "Vrapče"

Zagreb, 10090, Croatia

RECRUITING

Klinika za psihijatriju "Vrapče"

Zagreb, 10090, Croatia

RECRUITING

Klinika za psihijatriju "Vrapče"

Zagreb, 10090, Croatia

RECRUITING

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, 10090, Croatia

RECRUITING

Local Institution - 0065

Vadodara, Gujarat, 390021, India

NOT YET RECRUITING

Local Institution - 0082

Belagavi, Karnataka, 590010, India

NOT YET RECRUITING

Chethana Center for Neuropsychiatry

Kozhikode, Kerala, 673009, India

RECRUITING

Local Institution - 0051

Ludhiana, Punjab, 141001, India

NOT YET RECRUITING

Asha Hospital - Hyderabad

Hyderabad, Telangana, 500034, India

RECRUITING

Local Institution - 0055

Hyderabad, Telangana, 500082, India

NOT YET RECRUITING

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

RECRUITING

Local Institution - 0096

Kolkata, West Bengal, 700025, India

NOT YET RECRUITING

Shalvata Mental Health Center

Hod HaSharon, Central District, 4534708, Israel

RECRUITING

Ness Ziona Mental Health Center

Ness Ziona, Central District, 7410001, Israel

RECRUITING

Local Institution - 0058

Petah Tikva, Central District, 4910002, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Central District, 5265601, Israel

RECRUITING

Be'er Sheva Mental Health Center

Beersheba, Southern District, 8461144, Israel

RECRUITING

Kfar Shaul Mental Health Center

Jerusalem, 9546105, Israel

RECRUITING

Local Institution - 0001

Milan, Lombardy, 20122, Italy

WITHDRAWN

Local Institution - 0056

Pisa, Tuscany, 56126, Italy

WITHDRAWN

Local Institution - 0007

Siena, Tuscany, 53100, Italy

WITHDRAWN

Local Institution - 0041

Ancona, 60126, Italy

WITHDRAWN

Local Institution - 0040

Genova, 16132, Italy

WITHDRAWN