NCT06951711 A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
| NCT ID | NCT06951711 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Bipolar Disorder Type I With Mania or Mania With Mixed Features |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 274 participants in total. It began in 2025-06-13 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06951711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Disorder Type I With Mania or Mania With Mixed Features. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06951711 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 274 participants.
Is NCT06951711 currently recruiting?
Yes, NCT06951711 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06951711 trial being conducted?
This trial is being conducted at Little Rock, United States, Rogers, United States, Culver City, United States, Riverside, United States and 11 additional locations.
Who is sponsoring the NCT06951711 clinical trial?
NCT06951711 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 274 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.