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NCT04820309 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
A Phase 3 study of Schizophrenia, sponsored by Karuna Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 20
- Study locations
NCT04820309 is a Phase 3 study of Schizophrenia that has completed, run by Karuna Therapeutics. The registered enrollment target is 566 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (161% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT04820309, a Phase 3 study of Schizophrenia, has completed, sponsored by Karuna Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Xanomeline and Trospium Chloride Capsules
Study Locations (20)
California
- Local Institution - 011-240 - Anaheim
- Advanced Research Center, Inc. - Anaheim
- Clinical Innovations, Inc - Bellflower
- Local Institution - 011-222 - Bellflower
- Local Institution - 011-263 - Bellflower
- Local Institution - 011-257 - Cerritos
- ATP Clinical Research Inc - Costa Mesa
- ATP Clinical Research, Inc. - Costa Mesa
- Local Institution - 011-206 - Culver City
- ProScience Research Group - Culver City
- Local Institution - 011-253 - Garden Grove
- Local Institution - 011-202 - Glendale
- Behavioral Clinical Research, Inc. - Glendale
- Omega Clinical Trials - La Habra
- Omega Clinical Trials - La Habra
- Alliance for Wellness dba Alliance for Research - Long Beach
Arkansas
- Local Institution - 011-238 - Little Rock
- Woodland International Research Group - Little Rock
- Local Institution - 011-201 - Rogers
- Woodland Research Northwest - Rogers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2021-06-02 |
| Est. Completion | 2024-05-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04820309
The ClinicalTrials.gov registry entry for NCT04820309 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 566 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (161% higher). The listed sponsor is Karuna Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Xanomeline and Trospium Chloride Capsules is the first listed.
NCT04820309 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04820309 about?
NCT04820309 is a clinical study titled "An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)". 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 ...
What is the current status of trial NCT04820309?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2021-06-02. Estimated completion is 2024-05-24.
What conditions does trial NCT04820309 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT04820309?
The interventions under investigation include: Xanomeline and Trospium Chloride Capsules (DRUG).
Who is sponsoring clinical trial NCT04820309?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04820309 being conducted?
This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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