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

NCT06929273 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Bipolar Disorder Type I With Mania

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

Lithium

Therapeutic dose

DRUG

Valproate

Therapeutic dose

DRUG

Lamotrigine

Therapeutic dose

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2028-06-13
Completion
2028-06-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • China
  • Croatia
  • Denmark
  • France
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • New Zealand
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929273 on ClinicalTrials.gov