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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: Recruiting Phase 3 study of Bipolar Disorder Type I With Mania, sponsored by Bristol-Myers Squibb.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06929273 shows while recruiting
NCT06929273 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
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 names 20 study sites across 5 states, led by 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
How this trial's enrollment target compares
Where NCT06929273's enrollment target sits among peer trials
450 838th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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