A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Phase 3

Recruiting

• Conditions: Bipolar Disorder Type I With Mania
• Interventions: Drug: KarXT; Drug: Lithium; Drug: Valproate; Drug: Lamotrigine

• Registration Number: NCT06929273
• Lead Sponsor: Bristol-Myers Squibb

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-16
• Study Start: 2025-07-18
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-04
• Last Update Posted: 2025-11-05
• Primary Completion: 2028-06-13
• Study Completion: 2028-06-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

• 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:

  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.
  2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  3. 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.
  4. 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.
  5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  7. Other protocol-defined Inclusion/Exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KarXT or Adjuvant KarXT	KarXT	-
KarXT or Adjuvant KarXT	Lithium	-
KarXT or Adjuvant KarXT	Valproate	-
KarXT or Adjuvant KarXT	Lamotrigine	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAEs)	Up to week 54

Secondary Outcome Measures

Name	Time	Method
Number of participants with AEs of special interest (AESIs)	Up to week 54
Number of participants with serious AEs (SAEs)	Up to week 54
Number of participants with TEAEs leading to treatment discontinuation	Up to week 52
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score	Up to week 54
Change from baseline in Simpson Angus Scale (SAS) score	Up to week 54
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score	Up to week 54
Change from baseline in International Prostate Symptom Score (IPSS)	Up to week 54	Only for males ≥ 45 years of age

Trial Locations

Locations (137)

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Arch Clinical Trials; 🇺🇸 St Louis, Missouri, United States

Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian; 🇷🇴 Bucharest, Romania

Local Institution - 0120; 🇺🇸 Glendale, Arizona, United States

Pillar Clinical Research - Richardson; 🇺🇸 Richardson, Texas, United States

Pillar Clinical Research- Little Rock; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0057; 🇺🇸 Rogers, Arkansas, United States

Advanced Research Center Inc.; 🇺🇸 Anaheim, California, United States

Clinical Innovations, Inc. dba CITrials; 🇺🇸 Riverside, California, United States

Local Institution - 0044; 🇺🇸 Cerritos, California, United States

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