Skip to main content

An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)

Completed · Phase 3 · NCT04820309

Conditions: Schizophrenia

At a glance

Research payments reported, 2025
$2.6M
U.S. investigators named
43
Sites paid
40
Planned or actual enrollment
566

About the trial

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Tested
Xanomeline and Trospium Chloride Capsules (drug)
Dates
Started 2021-06-02; completion 2024-05-24
Results posted
Yes

This is a Phase 3, multicenter, 56-week, outpatient, open-label (OL) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in de novo subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia. In this OL study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) for up to 52 weeks. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and characterize the pharmacokinetics of xanomeline and trospium after ad…

From ClinicalTrials.gov, last updated 2025-09-17. Full record, eligibility and contacts (opens in a new tab)

Industry funding

E.r. Squibb & Sons, L.l.c. reported $2.6M in research payments for this study in 2025 (45 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

  • Cenexel Atlanta $556,921
  • Clinical Research Advantage, Incorporated $469,008
  • Clinical Innovations Inc $387,527
  • Cbh Health, Llc $291,374
  • Advanced Research Center $141,233
  • Omega Clinical Trials - La Habra $130,710
  • Collaborative Neuroscience Network $124,568
  • Premier Clinical Research Institute $94,860
  • Neuropsychiatric Research Center of Orange County $54,759
  • Research Centers of America $49,169
  • Elias Research Associates Llc $33,329
  • Behavioral Research Specialists, Llc $30,652
  • Cenexel Iresearch Atlanta $23,830
  • Cincy Science $21,179
  • Community Clinical Research $20,137
  • Uptown Research Institute, Llc $19,475
  • Arch Clinical Trials $19,169
  • Northwest Clinical Research Center $17,906
  • Innovative Clinical Research Inc $17,548
  • Proscience Research Group $17,540
  • Elligo Health Research, Inc $16,769
  • Insite Clinical Research $13,863
  • The Ima Group $12,951
  • California Neuropsychopharmacology Clinical Research Institute $10,950
  • Princeton Medical Institute $9,370
  • Health Synergy Clinical Research $8,890
  • Asclepes Research Centers $8,472
  • Schuster Medical Research Institute $4,906
  • Suburban Research Associates $4,865
  • Neuro Behavioral Clinical Research $4,550
  • Core Clinical Research $3,873
  • Saint Charles Psychiatric Associates and Midwest Research Group $3,740
  • Inspira Caguas $3,427
  • Excell Research $3,103
  • Psychiatric Consultants $2,500
  • Siyan Clinical Corporation $2,341
  • Interspond, Llc $1,821
  • Neurology Associates of Ormond Beach $1,711
  • Clinnova Research Solutions $1,500
  • Biobehavioral Research of Austin $1,200

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