A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Conditions

• Bipolar Disorder Type I With Mania or Mania With Mixed Features

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• KarXT — DRUG
  Specified dose on specified days
• Placebo — OTHER
  Specified dose on specified days

Study Details

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Key Dates

Start date

Jun 13, 2025

Status verified

Jun 2026

Primary completion

Nov 2, 2026

Completion

Nov 2, 2026

Study Design

Enrollment

274 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: KarXT
  Flexible dosing
• Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in Young Mania Rating Scale (YMRS) score [ Time Frame: At week 3 ]

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 (28)

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