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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06929273

Registry updated: 2026-09-14
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Description

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.

Interventions

  • KarXT (Drug)
    Specified dose on specified days
  • Lithium (Drug)
    Therapeutic dose
  • Valproate (Drug)
    Therapeutic dose
  • Lamotrigine (Drug)
    Therapeutic dose

Eligibility criteria

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: * All participants: 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. * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): 1\. Discontinuation from any KarXT parent studies. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 2. 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. 3. 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. 4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. * Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions

Bipolar Disorder Type I With Mania

Locations

  • Local Institution - 0120 — Glendale, Arizona, United States
  • Local Institution - 0204 — Scottsdale, Arizona, United States
  • Local Institution - 0205 — Tucson, 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
  • Local Institution - 0201 — 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
  • Local Institution - 0200 — Northridge, California, United States
  • NRC Research Institute — Orange, California, United States
  • Clinical Innovations, Inc. dba CITrials — Riverside, California, United States
  • Local Institution - 0136 — Santa Ana, California, United States
  • Collaborative Neuroscience Research, LLC — Torrance, California, United States
  • Local Institution - 0203 — Colorado Springs, Colorado, United States
  • Yale New Haven Hospital-Smilow Cancer Center — 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 - 0197 — Lincoln, Nebraska, 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
  • Local Institution - 0202 — West Chester, Ohio, United States
  • Community Clinical Research — Austin, Texas, United States
  • Local Institution - 0199 — Carrollton, Texas, United States
  • Adams Clinical Dallas — DeSoto, Texas, United States
  • Local Institution - 0046 — Houston, Texas, United States
  • Elevate Clinical Research-Houston — 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 - 0198 — Wichita Falls, Texas, United States
  • Local Institution - 0128 — ABB, Buenos Aires F.D., Argentina
  • Sanatorio Morra S.A. — Córdoba, Argentina
  • Local Institution - 0126 — Mendoza, Argentina
  • Ramsay Clinic Northside — St Leonards, New South Wales, Australia
  • Ramsay Clinic New Farm — Brisbane, Queensland, Australia
  • Local Institution - 0188 — Kazanlak, Stara Zagora, Bulgaria
  • Center for Mental Health Prof. Dr. Ivan Temkov — Burgas, Bulgaria
  • Local Institution - 0191 — Haskovo, 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 - 0184 — Changsha, Hunan, China
  • Local Institution - 0180 — Nanjing, Jiangsu, China
  • Xi An Mental Health Center — 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
  • Klinika za psihijatriju "Vrapče" — Zagreb, Croatia
  • Psihijatrijska bolnica "Sveti Ivan" — Zagreb, Croatia
  • Aalborg Universitetshospital Psykiatrien — Gistrup, Denmark
  • Glostrup Hospital — Glostrup Municipality, 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
  • Semmelweis Egyetem — Budapest, Hungary
  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet — Budapest, Hungary
  • Local Institution - 0111 — Vadodara, Gujarat, India
  • Local Institution - 0132 — Belagavi, Karnataka, India
  • Local Institution - 0190 — Mangalore, Karnataka, India
  • Chethana Center for Neuropsychiatry — Kozhikode, Kerala, India
  • Dayanand Medical College and Hospital — Ludhiana, Punjab, India
  • Local Institution - 0158 — Madurai, Tamil Nadu, India
  • Asha Hospital - Hyderabad — Hyderabad, Telangana, India
  • Local Institution - 0080 — Hyderabad, Telangana, India
  • Nil Ratan Sircar Medical College and Hospital — Kolkata, West Bengal, India
  • Local Institution - 0160 — Kolkata, West Bengal, India
  • Shalvata Mental Health Center — Hod HaSharon, Central District, Israel
  • Ness Ziona Mental Health Center — 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
  • Barzilai Medical Center — Ashkelon, Israel
  • Local Institution - 0168 — Jerusalem, Israel
  • Kfar Shaul Mental Health Center — Jerusalem, Israel
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy
  • Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy
  • Azienda Ospedaliero Universitaria Senese — Siena, Tuscany, Italy
  • Azienda Ospedaliero Universitaria delle Marche — Ancona, Italy
  • IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino — 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
  • Hino Hospital - Yokohama — 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
  • Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan
  • Nippon Medical School Hospital — Bunkyo-ku, Tokyo, Japan
  • National Center of Neurology and Psychiatry — Kodaira, Tokyo, Japan
  • Narimasu Kosei Hospital — tabashi City, Tokyo, Japan
  • Kuramitsu Hospital — Fukuoka, Japan
  • Kochi Health Sciences Center — 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
  • Instytut Psychiatrii i Neurologii — Warsaw, Masovian Voivodeship, Poland
  • Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku — Bialystok, Podlaskie Voivodeship, Poland
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Pomeranian Voivodeship, Poland
  • M2M Med — Rybnik, Silesian Voivodeship, Poland
  • Clinica Inventiva — Tuszyn, Poland
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania
  • Institutul Național de Gerontologie și Geriatrie "Ana Aslan" — Bucharest, Romania
  • Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian — Bucharest, Romania
  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila — Bucharest, Romania
  • Local Institution - 0097 — Iași, Romania
  • Spitalul de Psihiatrie și Neurologie Brașov — Sanpetru /Brasov, Romania
  • Local Institution - 0119 — Košice, Košice Region, Slovakia
  • Univerzitna Nemocnica L. Pasteura Kosice — Košice, Košice Region, Slovakia
  • Local Institution - 0117 — Vranov nad Topľou, Presov, Slovakia
  • Local Institution - 0115 — Barcelona, Barcelona [Barcelona], Spain
  • Osi Bilbao-Basurto — Bilbao, Basque Country, Spain
  • Hospital Clínic de Barcelona — Barcelona, Catalunya [Cataluña], Spain
  • Nacka Local Hospital — Nacka, Stockholms Län [se-01], Sweden
  • Local Institution - 0112 — Uppsala, Uppsala Län [se-03], Sweden
  • Local Institution - 0116 — Gothenburg, Västra Götalands Län [se-14], Sweden
  • Local Institution - 0152 — Smila, Cherkasy Oblast, Ukraine
  • Local Institution - 0146 — Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
  • Local Institution - 0143 — Hlevakha, Kyivska Oblast, Ukraine
  • Local Institution - 0147 — Lviv, Lviv Oblast, Ukraine
  • Local Institution - 0145 — Odesa, Odesa Oblast, Ukraine
  • Local Institution - 0148 — Vinnytsia, Vinnytsia Oblast, Ukraine
  • Local Institution - 0149 — Dnipro, Ukraine
  • Local Institution - 0151 — Kropyvnytskyi, Ukraine
  • Local Institution - 0150 — Kyiv, Ukraine
  • Local Institution - 0144 — Odesa, Ukraine
  • Local Institution - 0141 — Poltava, Ukraine
  • Local Institution - 0189 — Ternopil, Ukraine
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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