A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
Public ClinicalTrials.gov record NCT04659161. 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
- NCT04659161
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 252 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
- Dec 16, 2020 (Actual)
- Primary completion
- May 24, 2022 (Actual)
- Completion
- May 24, 2022 (Actual)
- Last update posted
- Dec 12, 2023
2020 – 2022
United States locations
- U.S. sites
- 22
- U.S. states
- 10
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| CITrials | Bellflower | California | 90706 | — |
| ProScience Research Institute | Culver City | California | 90230 | — |
| California Clinical Trials 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 | 92101 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | — |
| Research Centers of America | Oakland Park | Florida | 33334 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Pillar Clinical Research | Lincolnwood | Illinois | 60712 | — |
| Arch Clinical Trials | St Louis | Missouri | 63118 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Community Clinical Research | Austin | Texas | 78754 | — |
| Pillar Clinical Research | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04659161, 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 12, 2023 · 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 NCT04659161 live on ClinicalTrials.gov.