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

NCT05304767 · ClinicalTrials.gov registry record · Phase 3

An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

A Phase 3 study of Schizophrenia, sponsored by Karuna Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
280
Enrollment target
20
Study locations

NCT05304767 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Karuna Therapeutics. The registered enrollment target is 280 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 4 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05304767, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Karuna Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
280 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.

Conditions Studied

Schizophrenia

Interventions

  • DRUG Xanomeline and Trospium Chloride Capsules

Study Locations (20)

California

  • Advanced Research Center, Inc. - Anaheim
  • CITrials - Bellflower - Bellflower
  • Local Institution - 110 - Cerritos
  • Local Institution - 167 - Culver City
  • Local Institution - 127 - Garden Grove
  • Local Institution - 152 - La Habra
  • Local Institution - 126 - Lafayette
  • Synergy Clinical Research of Escondido - Lemon Grove
  • Local Institution - 141 - Los Angeles
  • Excell Research, Inc. - Oceanside
  • NRC Research Institute - Orange
  • CNRI - Los Angeles, LLC - Pico Rivera
  • CITrials, Inc. - Riverside & San Bernardino County - Riverside
  • Local Institution - 193 - San Diego
  • Local Institution - 164 - Stanford
  • Local Institution - 109 - Torrance

Arkansas

  • Pillar Clinical Research LLC - Little Rock
  • Woodland International Research Group, LLC - Little Rock

Arizona

  • Alea Research - Phoenix

Florida

  • Prestige Clinical Research Center, Inc. - Coral Gables

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2022-03-07
Est. Completion 2026-03-19
Phase Phase 3

Sponsor

Karuna Therapeutics

11 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05304767

The ClinicalTrials.gov registry entry for NCT05304767 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (28% 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.

NCT05304767 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arkansas, Arizona.

Frequently Asked Questions

What is clinical trial NCT05304767 about?

NCT05304767 is a clinical study titled "An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia". This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment perio...

What is the current status of trial NCT05304767?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2022-03-07. Estimated completion is 2026-03-19.

What conditions does trial NCT05304767 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT05304767?

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

Who is sponsoring clinical trial NCT05304767?

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

Where is trial NCT05304767 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Schizophrenia

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.