Status:
RECRUITING
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder Type I With Mania
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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 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.
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 13 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06929273
Start Date
July 18 2025
End Date
June 13 2028
Last Update
December 23 2025
Active Locations (157)
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1
Local Institution - 0120
Glendale, Arizona, United States, 85304
2
Pillar Clinical Research - Richardson
Bentonville, Arkansas, United States, 72712
3
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
4
Woodland International Research Group
Little Rock, Arkansas, United States, 72211