Trial · NCT06929273
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
NCT06929273, Phase 3, Recruiting, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3). Trials, record NCT06929273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06929273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
- NCT number
- NCT06929273
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 450 participants, estimated
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Bipolar Disorder Type I With Mania
- Interventions
- KarXT, Lithium, Valproate, Lamotrigine
- First posted
- 2025-04-16
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment emergent adverse events (TEAEs) | Up to week 54 | |
| Secondary | Number of participants with AEs of special interest (AESIs) | Up to week 54 | |
| Secondary | Number of participants with serious AEs (SAEs) | Up to week 54 | |
| Secondary | Number of participants with TEAEs leading to treatment discontinuation | Up to week 52 | |
| Secondary | Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to week 54 | |
| Secondary | Change from baseline in Barnes Akathisia Rating Scale (BARS) score | Up to week 54 | |
| Secondary | Change from baseline in Simpson Angus Scale (SAS) score | Up to week 54 | |
| Secondary | Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score | Up to week 54 | |
| Secondary | Change from baseline in International Prostate Symptom Score (IPSS) | Up to week 54 | Only for males ≥ 45 years of age |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06929273
GET https://conductscience.org/api/trials/v1/NCT06929273/registered