Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia

NCT03697252 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo Capsules
  • DRUG Xanomeline and Trospium Chloride Capsules

Study Locations (12)

California

  • Synergy East — Lemon Grove
  • Collaborative Neuroscience Network, LLC. — Long Beach
  • NRC Research Institute — Orange
  • Artemis Institute for Clinical Research — San Diego

Texas

  • Community Clinical Research, Inc. — Austin
  • InSite Clinical Research, LLC — DeSoto
  • Pillar Clinical Research, LLC — Richardson

Arkansas

  • Woodland International Research Group, LLC — Little Rock

Georgia

  • Atlanta Center for Medical Research — Atlanta

Maryland

  • CBH Health, LLC — Gaithersburg

New Jersey

  • Hassman Research Institute — Berlin

Ohio

  • Midwest Clinical Research Center (and IP Shipment) — Dayton

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2018-09-18
Est. Completion 2019-09-04
Phase Phase 2

Sponsor

Karuna Therapeutics

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03697252

The ClinicalTrials.gov registry entry for NCT03697252 describes a study currently listed as completed. It is categorized as Phase 2, 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 182 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 2 interventions — of which Placebo 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: NCT03697252 reports 12 study locations spanning 7 distinct geographic areas — top geographies include California, Texas, 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 NCT03697252 about?

NCT03697252 is a clinical study titled "A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia". 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 effic...

What is the current status of trial NCT03697252?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2018-09-18. Estimated completion is 2019-09-04.

What conditions does trial NCT03697252 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 NCT03697252?

The interventions under investigation include: Placebo Capsules (DRUG), 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 NCT03697252?

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 NCT03697252 being conducted?

This trial has 12 study locations across Arkansas, California, Georgia, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial