A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
Public ClinicalTrials.gov record NCT03697252. 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 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) (xanomeline 125 mg/trospium 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
Study identification
- NCT ID
- NCT03697252
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 182 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 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
- Sep 17, 2018
- Primary completion
- Sep 3, 2019
- Completion
- Sep 3, 2019
- Last update posted
- Oct 25, 2020
2018 – 2019
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| Synergy East | Lemon Grove | California | 91945 | — |
| Collaborative Neuroscience Network, LLC. | Long Beach | California | 90806 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| CBH Health, LLC | Gaithersburg | Maryland | 20877 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Midwest Clinical Research Center (and IP Shipment) | Dayton | Ohio | 45417 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| InSite Clinical Research, LLC | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03697252, 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 25, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03697252 live on ClinicalTrials.gov.