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

RECRUITING

NCT06951711

PHASE3

Sponsor: Bristol-Myers Squibb

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2025-06-13

Completion Date

2026-11-02

Last Updated

2026-04-07

Healthy Volunteers

No

Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed Features

Interventions

DRUG

KarXT

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Locations (69)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Proscience Research Group

Culver City, California, United States

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Local Institution - 0036

Hialeah Gardens, Florida, United States

Behavioral Clinical Research

Hollywood, Florida, United States

LCC Medical Research Institute

Miami, Florida, United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

South Florida Research Phase I-IV

Miami Springs, Florida, United States

Local Institution - 0019

Tampa, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Local Institution - 0020

Chicago, Illinois, United States

CBH Health

Gaithersburg, Maryland, United States

Precise Research Centers

Flowood, Mississippi, United States

Arch Clinical Trials

St Louis, Missouri, United States

Local Institution - 0076

North Las Vegas, Nevada, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

Local Institution - 0031

Marlton, New Jersey, United States

Local Institution - 0075

Charlotte, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

InSite Clinical Research

DeSoto, Texas, United States

Local Institution - 0028

Houston, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Local Institution - 0009

Zagreb, City of Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Local Institution - 0078

Zagreb, Croatia

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, Croatia

Local Institution - 0065

Vadodara, Gujarat, India

Local Institution - 0082

Belagavi, Karnataka, India

Local Institution - 0053

Kozhikode, Kerala, India

Local Institution - 0051

Ludhiana, Punjab, India

Local Institution - 0052

Hyderabad, Telangana, India

Local Institution - 0055

Hyderabad, Telangana, India

Local Institution - 0054

Kolkata, West Bengal, India

Shalvata Mental Health Center

Hod HaSharon, Central District, Israel

Local Institution - 0046

Ness Ziona, Central District, Israel

Local Institution - 0058

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Be'er Sheva Mental Health Center

Beersheba, Southern District, Israel

Kfar Shaul Mental Health Center

Jerusalem, Israel

Local Institution - 0001

Milan, Lombardy, Italy

Local Institution - 0056

Pisa, Tuscany, Italy

Local Institution - 0007

Siena, Tuscany, Italy

Local Institution - 0041

Ancona, Italy

Local Institution - 0040

Genova, Italy