ClinicalTrials.gov record
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
ClinicalTrials.gov ID: NCT04820309
Public ClinicalTrials.gov record NCT04820309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects With DSM-5 Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 administration of KarXT.
Study identification
- NCT ID
- NCT04820309
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 566 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2021
- Primary completion
- May 23, 2024
- Completion
- May 23, 2024
- Last update posted
- Sep 16, 2025
2021 – 2024
United States locations
- U.S. sites
- 116
- U.S. states
- 22
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 011-238 | Little Rock | Arkansas | 72211-3702 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Local Institution - 011-201 | Rogers | Arkansas | 72758 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Local Institution - 011-240 | Anaheim | California | 92805-5854 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Clinical Innovations, Inc | Bellflower | California | 90706 | — |
| Local Institution - 011-222 | Bellflower | California | 90706 | — |
| Local Institution - 011-263 | Bellflower | California | 90706 | — |
| Local Institution - 011-257 | Cerritos | California | 90703 | — |
| ATP Clinical Research Inc | Costa Mesa | California | 92626 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| Local Institution - 011-206 | Culver City | California | 90230 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Local Institution - 011-253 | Garden Grove | California | 92845 | — |
| Local Institution - 011-202 | Glendale | California | 91206-4282 | — |
| Behavioral Clinical Research, Inc. | Glendale | California | 91206 | — |
| Omega Clinical Trials | La Habra | California | 90631-3842 | — |
| Omega Clinical Trials | La Habra | California | 90631 | — |
| Alliance for Wellness dba Alliance for Research | Long Beach | California | 90807 | — |
| Alliance for Wellness | Long Beach | California | 90807 | — |
| North County Clinical Research (NCCR) | Oceanside | California | 92054 | — |
| Excell Research Inc | Oceanside | California | 92056 | — |
| Local Institution - 011-229 | Oceanside | California | 92056 | — |
| Local Institution - 011-242 | Orange | California | 92868 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| CNRI-Los Angeles, LLC | Pico Rivera | California | 90660 | — |
| Local Institution - 011-244 | Pico Rivera | California | 90660 | — |
| CITrials | Riverside | California | 92506 | — |
| Local Institution - 011-233 | Riverside | California | 92506 | — |
| CITrials | Santa Ana | California | 92705 | — |
| Local Institution - 011-251 | Santa Rosa | California | 95401-4691 | — |
| Siyan Clinical Research | Santa Rosa | California | 95401 | — |
| Local Institution - 011-246 | Sherman Oaks | California | 91403-1747 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Collaborative Neuroscience Research | Torrance | California | 90502 | — |
| Local Institution - 011-252 | Torrance | California | 90504 | — |
| Local Institution - 011-224 | Hallandale | Florida | 33009 | — |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | — |
| Local Institution - 011-261 | Hollywood | Florida | 33024 | — |
| Homestead Research Institute, Inc. | Homestead | Florida | 33030 | — |
| Local Institution - 011-231 | Homestead | Florida | 33030 | — |
| Local Institution - 011-203 | Miami | Florida | 33122-1335 | — |
| Premier Clinical Research Institute | Miami | Florida | 33122 | — |
| Central Miami Medical Institute | Miami | Florida | 33125 | — |
| Local Institution - 011-215 | Miami | Florida | 33125 | — |
| Local Institution - 011-220 | Miami | Florida | 33165 | — |
| Phoenix Medical Research | Miami | Florida | 33165 | — |
| Innovative Clinical Research | Miami Lakes | Florida | 33016 | — |
| Local Institution - 011-234 | Miami Lakes | Florida | 33016 | — |
| Research Centers of America at Fort Lauderdale Behavioral Health Center | Oakland Park | Florida | 33334 | — |
| Health Synergy Clinical Research | Okeechobee | Florida | 34972 | — |
| Local Institution - 011-216 | Okeechobee | Florida | 34972 | — |
| Local Institution - 011-219 | Pembroke Pines | Florida | 33024 | — |
| Pines Care Research Center | Pembroke Pines | Florida | 33024 | — |
| Local Institution - 011-262 | West Palm Beach | Florida | 33407 | — |
| Neuroscience Research Institute | West Palm Beach | Florida | 33407 | — |
| Local Institution - 011-259 | Atlanta | Georgia | 30328 | — |
| Synexus Clinical Research US, Inc. | Atlanta | Georgia | 30328 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Local Institution - 011-237 | Atlanta | Georgia | 30331 | — |
| Local Institution - 011-235 | Decatur | Georgia | 30030-2549 | — |
| Local Institution - 011-204 | Chicago | Illinois | 60640-5017 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Local Institution - 011-223 | Wichita | Kansas | 67214-2878 | — |
| Ascension Via Christi Research | Wichita | Kansas | 67214 | — |
| Local Institution - 011-205 | Shreveport | Louisiana | 71101 | — |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | — |
| CBH Health, LLC | Gaithersburg | Maryland | 20877 | — |
| Local Institution - 011-211 | Gaithersburg | Maryland | 20877 | — |
| Local Institution - 011-232 | Ann Arbor | Michigan | 48105-3205 | — |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | — |
| Local Institution - 011-226 | Flowood | Mississippi | 39170 | — |
| Precise Research Centers | Flowood | Mississippi | 39170 | — |
| Local Institution - 011-227 | Saint Charles | Missouri | 63304 | — |
| Midwest Research Group - St. Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | — |
| St. Charles Psychiatric Associates/Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Arch Clinical Trials | St Louis | Missouri | 63118 | — |
| Local Institution - 011-241 | St Louis | Missouri | 63141 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Local Institution - 011-239 | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Local Institution - 011-230 | Berlin | New Jersey | 08009 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Local Institution - 011-249 | Marlton | New Jersey | 08053 | — |
| Local Institution - 011-256 | New York | New York | 10036 | — |
| Manhattan Behavioral Medicine, PLLC | New York | New York | 10036 | — |
| Local Institution - 011-210 | New York | New York | 10128 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Local Institution - 011-250 | Rochester | New York | 14618 | — |
| Clinical Trials of America | Hickory | North Carolina | 28601 | — |
| Local Institution - 011-218 | Dayton | Ohio | 45417 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Local Institution - 011-248 | North Canton | Ohio | 44720 | — |
| Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | 44720 | — |
| Cincy Science | West Chester | Ohio | 45069 | — |
| Local Institution - 011-221 | West Chester | Ohio | 45069 | — |
| SP Research PLLC | Oklahoma City | Oklahoma | 73112 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Global Medical Institutes LLC Scranton Medical Institute | Moosic | Pennsylvania | 18507 | — |
| Local Institution - 011-207 | West Chester | Pennsylvania | 19380 | — |
| Psychiatric Consultants | Franklin | Tennessee | 37067 | — |
| Community Clinical Research | Austin | Texas | 78754 | — |
| Local Institution - 011-243 | Austin | Texas | 78754 | — |
| BioBehavioral Research of Austin P.C. | Austin | Texas | 78759 | — |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | — |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | — |
| Local Institution - 011-236 | DeSoto | Texas | 75115 | — |
| Local Institution - 011-258 | Fort Worth | Texas | 76104 | — |
| Core Clinical Research | Richmond | Texas | 77407 | — |
| healthTx | Richmond | Texas | 77407 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
| Local Institution - 011-209 | Bellevue | Washington | 98007-4879 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Local Institution - 011-260 | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04820309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04820309 live on ClinicalTrials.gov.