Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06929273 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
A Phase 3 study of Bipolar Disorder Type I With Mania, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06929273 is a Phase 3 study of Bipolar Disorder Type I With Mania that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 450 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT06929273, a Phase 3 study of Bipolar Disorder Type I With Mania, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Lamotrigine
- DRUG Lithium
- DRUG Valproate
- DRUG KarXT
Study Locations (20)
California
- Advanced Research Center Inc. - Anaheim
- Clinical Innovations, Inc. dba CITrials - Bellflower
- Local Institution - 0044 - Cerritos
- Inland Psychiatric Medical Group - Chino - Chino
- Proscience Research Group - Culver City
- Collaborative Neuroscience Research, LLC - Garden Grove
- Local Institution - 0137 - La Habra
- Catalina Research Institute, LLC - Montclair
- NRC Research Institute - Orange
- Clinical Innovations, Inc. dba CITrials - Riverside
- Collaborative Neuroscience Research, LLC - Torrance
Arkansas
- Pillar Clinical Research - Richardson - Bentonville
- Pillar Clinical Research- Little Rock - Little Rock
- Woodland International Research Group - Little Rock
- Woodland Research Northwest - Rogers
Florida
- Velocity Clinical Research, Hallandale Beach - Hallandale
- Local Institution - 0026 - Hialeah Gardens
- Behavioral Clinical Research - Hollywood
Arizona
- Local Institution - 0120 - Glendale
Connecticut
- Local Institution - 0131 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2028-06-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06929273
The ClinicalTrials.gov registry entry for NCT06929273 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder Type I With Mania appearing as the primary indexed condition, and to 4 interventions - of which Lamotrigine is the first listed.
NCT06929273 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT06929273 about?
NCT06929273 is a clinical study titled "A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)". 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 participant...
What is the current status of trial NCT06929273?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2025-07-18. Estimated completion is 2028-06-13.
What conditions does trial NCT06929273 study?
This clinical trial studies the following conditions: Bipolar Disorder Type I With Mania.
What interventions are being tested in trial NCT06929273?
The interventions under investigation include: Lamotrigine (DRUG), Lithium (DRUG), Valproate (DRUG), KarXT (DRUG).
Who is sponsoring clinical trial NCT06929273?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06929273 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.