An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
Public ClinicalTrials.gov record NCT04659174. 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 Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Subjects With DSM-5 Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, multicenter, 53-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia who previously completed the treatment period of one of the two Phase 3 double-blind studies, KAR-007 or KAR-009. In this OLE 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 regardless of treatment assignment in the preceding Phase 3 acute study. 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 monitor trough concentrations of xanomeline and trospium after administration of KarXT.
Study identification
- NCT ID
- NCT04659174
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 152 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
- Feb 1, 2021 (Actual)
- Primary completion
- Oct 3, 2023 (Actual)
- Completion
- Oct 3, 2023 (Actual)
- Last update posted
- Oct 28, 2024
2021 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 10
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Advanced Research Center Inc | Bellflower | California | 90706 | — |
| CITrials | Bellflower | California | 90706 | — |
| Proscience Research Group | Culver City | California | 90230 | — |
| Collaborative NeuroScience Research, LLC | Garden Grove | California | 92845 | — |
| California Clinical Trial Medical Group | Glendale | California | 91206 | — |
| Synergy San Diego | Lemon Grove | California | 91945 | — |
| CNS Network | Long Beach | California | 90806 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| California Neuropsychopharmacology Clinical Research Institute | Pico Rivera | California | 90660 | — |
| California Neuropsychopharmacology Clinical Research Institute | San Diego | California | 92102 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Collaborative Neuroscience Research, LLC. | Torrance | California | 90502 | — |
| Behavioral Clinical Research, Inc. | Hollywood | Florida | 33021 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Mitchell L. Glaser | Chicago | Illinois | 60622 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| AMITA Health Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Pillar Clinical Research | Lincolnwood | Illinois | 60712 | — |
| Arch Clinical Trials | St Louis | Missouri | 63125 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | — |
| Community Clinical Research | Austin | Texas | 78754 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04659174, 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 Oct 28, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04659174 live on ClinicalTrials.gov.