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

Conditions

• Bipolar Disorder Type I With Mania

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• KarXT — DRUG
  Specified dose on specified days
• Lithium — DRUG
  Therapeutic dose
• Valproate — DRUG
  Therapeutic dose
• Lamotrigine — DRUG
  Therapeutic dose

Study Details

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.

Key Dates

Start date

Jul 18, 2025

Status verified

Jun 2026

Primary completion

Jun 13, 2028

Completion

Jun 13, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: KarXT or Adjuvant KarXT

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to week 54 ]

Central Contacts

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  855-907-3286
  [email protected]
• First line of the email MUST contain NCT # and Site #.

Locations (52)

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