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NCT06951711 · 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 (BALSAM-2)
A Phase 3 study of Bipolar Disorder Type I 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
NCT06951711: Recruiting Phase 3 study of Bipolar Disorder Type I With Mania or Mania With Mixed Features, sponsored by Bristol-Myers Squibb.
NCT06951711 is a Phase 3 study of Bipolar Disorder Type I With Mania or Mania With Mixed Features that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06951711, a Phase 3 study of Bipolar Disorder Type I 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
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Primary Outcome
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG KarXT
Study Locations (20)
Florida
- Local Institution - 0036 - Hialeah Gardens
- Behavioral Clinical Research - Hollywood
- LCC Medical Research Institute - Miami
- Innovative Clinical Research, Inc. - Miami Lakes
- South Florida Research Phase I-IV - Miami Springs
- Local Institution - 0019 - Tampa
- Health Synergy Clinical Research - West Palm Beach
California
- Proscience Research Group - Culver City
- Clinical Innovations, Inc. dba CITrials - Riverside
- Collaborative Neuroscience Research, LLC - Torrance
Arkansas
- Pillar Clinical Research- Little Rock - Little Rock
- Woodland Research Northwest - Rogers
Georgia
- Atlanta Center for Medical Research - Atlanta
- CenExel iResearch, LLC - Decatur
Illinois
- Local Institution - 0020 - Chicago
Maryland
- CBH Health - Gaithersburg
Mississippi
- Precise Research Centers - Flowood
Missouri
- Arch Clinical Trials - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2026-11-02 |
| Phase | Phase 3 |
What NCT06951711 shows while recruiting
NCT06951711 is an interventional study that assigns participants to a tested intervention. The registered 274 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 (65% lower).
The record links to 1 condition, with Bipolar Disorder Type I With Mania or Mania With Mixed Features appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06951711 names 20 study sites across 10 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06951711 about?
NCT06951711 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 (BALSAM-2)". This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in tre...
What is the current status of trial NCT06951711?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2025-06-13. Estimated completion is 2026-11-02.
What conditions does trial NCT06951711 study?
This clinical trial studies the following conditions: Bipolar Disorder Type I With Mania or Mania With Mixed Features.
What interventions are being tested in trial NCT06951711?
The interventions under investigation include: Placebo (OTHER), KarXT (DRUG).
Who is sponsoring clinical trial NCT06951711?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951711 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06951711's enrollment target sits among peer trials
274 1208th of 2000 higher than 788 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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