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NCT03697252 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Schizophrenia, sponsored by Karuna Therapeutics.

Completed
Registry status
Phase 2
Development phase
182
Enrollment target
12
Study locations

NCT03697252 is a Phase 2 study of Schizophrenia that has completed, run by Karuna Therapeutics. The registered enrollment target is 182 participants, below the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (17% lower). The trial reports 12 study locations across 7 states.

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The verdict

NCT03697252, a Phase 2 study of Schizophrenia, has completed, sponsored by Karuna Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
182 participants
Enrollment target
12
Study locations

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

Schizophrenia

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

11 total trials

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What the Registry Record Tells You About NCT03697252

The ClinicalTrials.gov registry entry for NCT03697252 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (17% lower). 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 2 interventions - of which Placebo Capsules is the first listed.

NCT03697252 reports 12 study locations spanning 7 distinct geographic areas - top geographies include California, Texas, Arkansas.

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.

What interventions are being tested in trial NCT03697252?

The interventions under investigation include: Placebo Capsules (DRUG), Xanomeline and Trospium Chloride Capsules (DRUG).

Who is sponsoring clinical trial NCT03697252?

This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.