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RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

NCT06951698 · View on ClinicalTrials.gov ↗

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

504 total trials

Interested in This Trial?

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06951698 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06951698?

The interventions under investigation include: Placebo (OTHER), KarXT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06951698?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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