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NCT06951698 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
A Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
- 20
- Study locations
NCT06951698 is a Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 274 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT06951698, a Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Conditions Studied
Interventions
- OTHER Placebo
- DRUG KarXT
Study Locations (20)
California
- Advanced Research Center Inc. - Anaheim
- CITrials - Bellflower
- Local Institution - 0014 - Cerritos
- Collaborative Neuroscience Research, LLC - Long Beach
- Catalina Research Institute, LLC - Montclair
- NRC Research Institute - Orange
Florida
- Research Centers of America ( Hollywood ) - Hollywood
- Advanced Research Institute of Miami - Homestead
- Innovative Clinical Research, Inc. - Miami Lakes
- Local Institution - 0015 - Miami Lakes
- South Florida Research Phase I-IV - Miami Springs
- Health Synergy Clinical Research - West Palm Beach
Arkansas
- Pillar Clinical Research - Bentonville - Bentonville
- Woodland International Research Group - Little Rock
Georgia
- Synexus Clinical Research US, Inc. - Atlanta
- CenExel iResearch, LLC - Savannah
Connecticut
- Connecticut Mental Health Center - New Haven
Illinois
- Pillar Clinical Research -Chicago - Chicago
New York
- Richmond Behavioral Associates - Staten Island
Ohio
- Neuro-Behavioral Clinical Research - North Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06951698
The ClinicalTrials.gov registry entry for NCT06951698 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 274 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-I Disorder With Mania or Mania With Mixed Features appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06951698 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06951698 about?
NCT06951698 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder". The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
What is the current status of trial NCT06951698?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2025-06-11. Estimated completion is 2026-11-01.
What conditions does trial NCT06951698 study?
This clinical trial studies the following conditions: Bipolar-I Disorder With Mania or Mania With Mixed Features.
What interventions are being tested in trial NCT06951698?
The interventions under investigation include: Placebo (OTHER), KarXT (DRUG).
Who is sponsoring clinical trial NCT06951698?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951698 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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