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A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Recruiting · Phase 3 · NCT06929273

Conditions: Bipolar Disorder Type I With Mania

At a glance

Research payments reported, 2025
$119,798
U.S. investigators named
52
Sites paid
46
Planned or actual enrollment
450

About the trial

Sponsor
Bristol-Myers Squibb
Tested
KarXT (drug), Lithium (drug), Valproate (drug), Lamotrigine (drug)
Dates
Started 2025-07-18; completion 2028-06-13
Results posted
Not yet

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

From ClinicalTrials.gov, last updated 2026-10-26. Full record, eligibility and contacts (opens in a new tab)

Industry funding

E.r. Squibb & Sons, L.l.c. reported $119,798 in research payments for this study in 2025 (63 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • South Florida Research Phase I To Iv, Inc $13,444
  • Pillar Clinical Research, Llc $7,541
  • Clinical Innovations, Incorporated $7,067
  • Cenexel Iresearch, Llc $4,903
  • Velocity Clinical Research Hallandale Beach $4,715
  • Advanced Research Institute of Miami $4,490
  • Elevate Synapsis - Atascocita $4,010
  • Trialmed $3,701
  • Proscience Research Group $3,700
  • Prime Clinical Research - Mansfield $3,668
  • Inland Psychiatric Medical Group, Inc $3,654
  • Omega Clinical Trials - La Habra $3,645
  • Richmond Behavioral Associates $3,311
  • Arch Clinical Trials $3,197
  • Community Clinical Research $3,050
  • Pillar Clinical Research- Little Rock $2,334
  • Central Texas Neurology Consultants $2,002
  • Pillar Clinical Research Llc $1,959
  • Health Synergy Clinical Research $1,716
  • Renstar Medical Research $1,668
  • Collaborative Neuroscience Network, Llc $1,627
  • Cbh Health, Llc $1,609
  • Research Centers of America $1,587
  • Advanced Research Center $1,491
  • Catalina Research Institute, Llc $1,491
  • Miami Lakes Medical Research $1,461
  • Behavioral Clinical Research $1,460
  • Yale-New Haven Hospital, CT $1,449
  • Insite Clinical Research $1,446
  • Cenexel Atlanta $1,443
  • Woodland Research Northwest, Llc $1,439
  • Woodland International Research Group $1,438
  • Neuro Behavioral Clinical Research $1,433
  • University of Cincinnati $1,427
  • NYU Langone Health $1,407
  • Georgetown University Medical Center $1,350
  • Stanford Neuroscience Health Center $1,326
  • Genesis Neuroscience Clinic $1,322
  • Dent Neurologic Institute $1,321
  • Neurology Clinic, PC $1,288
  • Healthpartners Neuroscience Center $1,247
  • Fraga Berrios, Ivone, Office $1,226
  • Neurology Diagnostics, Inc $1,202
  • Research of the Rockies $1,190
  • Intercoastal Medical Group $1,173
  • Alexian Brothers Neurosciences Institute Clinical Research $1,171

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.