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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.

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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

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

FieldValue
Enrollment Target 274 participants
Start Date 2025-06-11
Est. Completion 2026-11-01
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.