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RECRUITING

NCT06929273

PHASE3

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Official title: A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-07-18

Completion Date

2028-06-13

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Bipolar Disorder Type I With Mania

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

Lithium

Therapeutic dose

DRUG

Valproate

Therapeutic dose

DRUG

Lamotrigine

Therapeutic dose

Inclusion Criteria: * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a. Participants must have completed treatment period of parent study. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania. 2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline. 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline. 4. Participants does not require hospitalization for acute mania. Exclusion Criteria: * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a. Discontinuation from any KarXT parent studies. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS. 2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 3. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 4. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test. 5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. 7. Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (170)

Local Institution - 0120

Glendale, Arizona, United States

Pillar Clinical Research - Richardson

Bentonville, Arkansas, United States

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Advanced Research Center Inc.

Anaheim, California, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

Local Institution - 0044

Cerritos, California, United States

Inland Psychiatric Medical Group - Chino

Chino, California, United States

Proscience Research Group

Culver City, California, United States

Collaborative Neuroscience Research, LLC

Garden Grove, California, United States

Omega Clinical Trials - La Habra

La Habra, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

NRC Research Institute

Orange, California, United States

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Local Institution - 0131

New Haven, Connecticut, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Local Institution - 0026

Hialeah Gardens, Florida, United States

Behavioral Clinical Research

Hollywood, Florida, United States

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

LCC Medical Research Institute

Miami, Florida, United States

Advanced Research Institute of Miami

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 - 0045

St. Petersburg, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Synexus Clinical Research US, Inc.

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Local Institution - 0031

Chicago, Illinois, United States

Pillar Clinical Research -Chicago

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 - 0121

North Las Vegas, Nevada, United States

Local Institution - 0122

North Las Vegas, Nevada, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

Local Institution - 0058

Marlton, New Jersey, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Local Institution - 0124

Charlotte, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

Community Clinical Research

Austin, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

Local Institution - 0046

Houston, Texas, United States

Local Institution - 0138

Houston, Texas, United States

Local Institution - 0036

Irving, Texas, United States

Prime Clinical Research - Mansfield

Mansfield, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Local Institution - 0128

ABB, Buenos Aires F.D., Argentina

Local Institution - 0127

Córdoba, Argentina

Local Institution - 0126

Mendoza, Argentina

Ramsay Clinic Northside

St Leonards, New South Wales, Australia

Ramsay Clinic New Farm

Brisbane, Queensland, Australia

Center for Mental Health Prof. Dr. Ivan Temkov

Burgas, Bulgaria

State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

Novi Iskar, Bulgaria

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

Pleven, Bulgaria

MHAT "Dr. Ival Seliminski"

Sliven, Bulgaria

Mental Health Center - Vratsa

Vratsa, Bulgaria

Local Institution - 0177

Beijing, Beijing Municipality, China

Local Institution - 0174

Beijing, Beijing Municipality, China

Local Institution - 0175

Guangzhou, Guangdong, China

Local Institution - 0181

Baoding, Hebei, China

Local Institution - 0185

Shijiazhuang, Hebei, China

Local Institution - 0184

Changsha, Hunan, China

Local Institution - 0180

Nanjing, Jiangsu, China

Local Institution - 0176

Xi'an, Shaanxi, China

Local Institution - 0179

Chengdu, Sichuan, China

Local Institution - 0183

Tianjin, Tianjin Municipality, China

Local Institution - 0182

Ningbo, Zhejiang, China

Local Institution - 0018

Zagreb, City of Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Local Institution - 0129

Zagreb, Croatia

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, Croatia

Local Institution - 0154

Glostrup Municipality, Capital Region, Denmark

Local Institution - 0153

Aalborg, North Denmark, Denmark

Local Institution - 0170

Nice, Alpes-Maritimes, France

Local Institution - 0171

Clermont-Ferrand, France

Local Institution - 0172

Montpellier, France

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Local Institution - 0110

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Local Institution - 0111

Vadodara, Gujarat, India

Local Institution - 0132

Belagavi, Karnataka, India

Local Institution - 0159

Mangalore, Karnataka, India

Local Institution - 0079

Kozhikode, Kerala, India

Local Institution - 0077

Ludhiana, Punjab, India

Local Institution - 0158

Madurai, Tamil Nadu, India

Local Institution - 0078

Hyderabad, Telangana, India

Local Institution - 0080

Hyderabad, Telangana, India

Local Institution - 0076

Kolkata, West Bengal, India

Local Institution - 0160

Kolkata, West Bengal, India

Shalvata Mental Health Center

Hod HaSharon, Central District, Israel

Local Institution - 0075

Ness Ziona, Central District, Israel

Local Institution - 0084

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Be'er Sheva Mental Health Center

Beersheba, Southern District, Israel

Local Institution - 0173

Ashkelon, Israel

Local Institution - 0187

Bnei Brak, Israel

Local Institution - 0168

Jerusalem, Israel

Kfar Shaul Mental Health Center

Jerusalem, Israel

Local Institution - 0066

Milan, Lombardy, Italy

Local Institution - 0083

Pisa, Tuscany, Italy

Local Institution - 0065

Siena, Tuscany, Italy

Local Institution - 0070

Ancona, Italy

Local Institution - 0069

Genova, Italy

Hotei Hospital

Kōnan, Aichi-ken, Japan

Okehazama Hospital

Toyoake, Aichi-ken, Japan

National Kohnodai Medical Center.

Ichikawa, Chiba, Japan

Local Institution - 0166

Iizuka, Fukuoka, Japan

Local Institution - 0063

Kitakyushu, Fukuoka, Japan

Obihiro Kosei Hospital

Obihiro, Hokkaido, Japan

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan

Local Institution - 0165

Yokohama, Kanagawa, Japan

Kansai Medical University Medical Center

Moriguchi, Osaka, Japan

Local Institution - 0007

Sakai-shi, Osaka, Japan

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan

Local Institution - 0016

Iruma, Saitama, Japan

Saitama Konan Hospital

Kumagaya, Saitama, Japan

Local Institution - 0163

Bunkyo-ku, Tokyo, Japan

Local Institution - 0164

Bunkyo-ku, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Local Institution - 0161

Kochi, Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Showa Medical University Karasuyama Hospital

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yamagata Sakuracho Hospital

Yamagata, Japan

North Shore Hospital

Auckland, New Zealand

Centrum Medyczne HCP

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0092

Warsaw, Masovian Voivodeship, Poland

Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku

Bialystok, Podlaskie Voivodeship, Poland

Local Institution - 0093

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0089

Rybnik, Silesian Voivodeship, Poland

Clinica Inventiva

Tuszyn, Poland

Local Institution - 0095

Bucharest, București, Romania