Recruiting NCT06929273

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

Phase III Interventional Bipolar Disorder Type I With Mania

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: KarXT, Lithium, Valproate, Lamotrigine.
Who it may be relevant to: Registry conditions: Bipolar Disorder Type I With Mania. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Bulgaria, China +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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 (BALSAM-3)

Overview

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]

Secondary outcome measures (8)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment