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An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
NCT04820309 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 566 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karuna Therapeutics, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04820309 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04820309?
The interventions under investigation include: Xanomeline and Trospium Chloride Capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04820309?
This trial is sponsored by Karuna Therapeutics, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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