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

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment in 1 month

Phase 3

Conditions

Bipolar Disorder Type I With Mania

Treatments

Drug: KarXT

Study type

Interventional

Funder types

Industry

Identifiers

NCT06929273

CN012-0038

2024-520259-26-00 (Other Identifier)

U1111-1316-9287 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

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 or CN0120037):

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, 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.