A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
Public ClinicalTrials.gov record NCT04738123. 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
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
Study identification
- NCT ID
- NCT04738123
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 256 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
- Apr 6, 2021 (Actual)
- Primary completion
- Nov 29, 2022 (Actual)
- Completion
- Dec 7, 2022 (Actual)
- Last update posted
- Dec 9, 2024
2021 – 2022
United States locations
- U.S. sites
- 20
- U.S. states
- 7
- U.S. cities
- 18
| 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 | — |
| Clinical Innovations, Inc | Bellflower | California | 90706 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Collaborative Neuroscience Research, LLC. | Garden Grove | California | 92845 | — |
| CNS Network | Long Beach | California | 90806 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Behavioral Clinical Research, Inc. | Hollywood | Florida | 33021 | — |
| Larkin Behavioral Health Services | Hollywood | Florida | 33021 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| AMITA Health Center for Psychiatric Research | Chicago | Illinois | 60622 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| AMITA Health Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | — |
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 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04738123, 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 Dec 9, 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 NCT04738123 live on ClinicalTrials.gov.