A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I … (NCT06929273) | Clinical Trial Compass
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
United States450 participantsStarted 2025-07-18
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 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.
✕
What they're measuring
1
Number of participants with treatment emergent adverse events (TEAEs)
Timeframe: Up to week 54
Trial details
NCT IDNCT06929273
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-06-13
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
. 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.