NCT06929273 · Bristol-Myers Squibb
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
What this study is about
This is a phase 3, where both patients and doctors know the treatment given 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 how well patients handle the treatment of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
View original scientific 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
DRUG
KarXT
Specified dose on specified days
DRUG
Lithium
Therapeutic dose
DRUG
Valproate
Therapeutic dose
DRUG
Lamotrigine
Therapeutic dose
Primary outcome measures
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to week 54
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
- Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
- Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
- 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:
- Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
- 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.
- 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.
- Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- 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.
Where
- Glendale, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Bentonville, Arkansas
- Little Rock, Arkansas
- Rogers, Arkansas
- Anaheim, California
- Bellflower, California
- Cerritos, California
- Chino, California
- Culver City, California
- Garden Grove, California
And 40 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations