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Muscarinic Agonist

KarXT for Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial dose through 7 days after the final dose (up to 53 weeks)
Awards & highlights

Study Summary

This trial is designed to study the long-term safety and efficacy of KarXT, a fixed combination of xanomeline and trospium chloride, in patients with DSM-5 schizophrenia. The primary objective is to assess safety and tolerability, while the secondary objective is to assess long-term efficacy and monitor drug concentrations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial dose through 7 days after the final dose (up to 53 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial dose through 7 days after the final dose (up to 53 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 52
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52
+5 more

Side effects data

From 2022 Phase 3 trial • 252 Patients • NCT04659161
21%
Constipation
19%
Nausea
19%
Dyspepsia
14%
Vomiting
13%
Headache
10%
Hypertension
9%
Dizziness
6%
Abdominal discomfort
6%
Diarrhoea
6%
Gastrooesophageal reflux disease
5%
Somnolence
5%
Dry mouth
5%
Vision blurred
5%
Anxiety
3%
Abdominal pain
3%
Heart rate increased
2%
Insomnia
2%
Suicidal ideation
2%
Orthostatic hypotension
2%
Salivary hypersecretion
2%
Back pain
2%
Agitation
1%
Psychotic disorder
1%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
KarXT
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: KarXTExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanomeline and Trospium Chloride Capsules
2021
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
12 Previous Clinical Trials
3,250 Total Patients Enrolled
9 Trials studying Schizophrenia
2,170 Patients Enrolled for Schizophrenia
Inder Kaul, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
1,356 Total Patients Enrolled
4 Trials studying Schizophrenia
1,356 Patients Enrolled for Schizophrenia

Media Library

KarXT (Muscarinic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04659174 — Phase 3
Schizophrenia Research Study Groups: KarXT
Schizophrenia Clinical Trial 2023: KarXT Highlights & Side Effects. Trial Name: NCT04659174 — Phase 3
KarXT (Muscarinic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659174 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT04659174 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research only consider patients who are 30 years or younger?

"The age restrictions for this trial (18-65) are different from other trials, which have a lower age limit of 18 or no age limit. Out of the total 223 clinical trials, 47 are for patients under 18 and 176 are for patients over 65."

Answered by AI

At how many sites is this trial being conducted?

"Recruitment for this trial is currently underway at 14 trial sites, which are located in Chicago, Hoffman Estates, Berlin, and 14 additional cities. To reduce the amount of travel required, it is best to select the trial site closest to you."

Answered by AI

Are patients still being accepted for this program?

"Yes, that is correct. The clinical trial was originally posted on February 1st, 2021 and is currently enrolling 350 patients at 14 hospitals."

Answered by AI

Has the FDA cleared Xanomeline and Trospium Chloride Capsules for public use?

"There is some clinical data to support the efficacy of Xanomeline and Trospium Chloride Capsules, and it has received a score of 3 for safety."

Answered by AI

Are there other examples of research using similar drugs to Xanomeline and Trospium Chloride Capsules?

"In 2020, the University of Pittsburgh conducted the first clinical trial for Xanomeline and Trospium Chloride Capsules. There have been a total of 20 completed studies since then. Right now, 5 studies are still active, with a high concentration of research taking place in Chicago, Illinois."

Answered by AI

How many human subjects are enrolled in this experiment?

"In order to run the trial 350 patients that meet the inclusion criteria are required. The sponsor, Karuna Therapeutics, has multiple sites where the trial will be conducted including CNS Network in Chicago, Illinois and Mitchell L. Glaser in Hoffman Estates, New jersey."

Answered by AI

Could I possibly be accepted to join this clinical trial?

"This study is looking for 350 participants, all of whom must be between 18 and 65 years old and currently living with schizophrenia. Additionally, it is important that participants meet the following criteria:- Reside in a stable living situation, in the opinion of the investigator.- Women of childbearing potential or men with sexual partners of childbearing potential must be sexually abstinent (in line with their preferred and usual lifestyle) or willing and able to use at least 1 highly effective method of contraception during the study and for at least 7 days after the last dose of KarXT. Sperm donation is not allowed for 7 days"

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Advanced Research Center Inc
Atlanta Center for Medical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

The opportunity to try out a study and find out what it can do for me...
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Atlanta Center for Medical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
2021. "An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04659174.
~37 spots leftby Apr 2025
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