← Back to Search

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
Subject is aged ≥18 to <60 years at the time of randomization of Study KAR-012
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial dose to safety follow-up visit (54 weeks) or early termination
Awards & highlights

Study Summary

This trial is studying the long-term safety and effectiveness of a combination of two drugs, xanomeline and trospium chloride, in people with schizophrenia who have not responded well to other antipsychotic treatments.

Who is the study for?
This trial is for adults aged 18-60 with schizophrenia who haven't responded well to current antipsychotic treatments. Participants must have completed the ARISE Study, be in a stable living situation, and have a reliable informant. Women of childbearing age must use contraception.Check my eligibility
What is being tested?
The study tests long-term safety and tolerability of KarXT (xanomeline and trospium chloride capsules) as an add-on treatment for schizophrenia over 52 weeks. It's open-label, meaning everyone knows they're getting the drug, not a placebo.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to trospium (like constipation or dry mouth), central nervous system effects from xanomeline (such as confusion or agitation), and other common drug-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 59 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial dose to safety follow-up visit (54 weeks) or early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial dose to safety follow-up visit (54 weeks) or early termination 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
Incidence of TEAEs leading to discontinuation of study drug
Incidence of serious treatment-emergent adverse events (TEAEs)

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: Drug: 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
3,126 Total Patients Enrolled
9 Trials studying Schizophrenia
2,046 Patients Enrolled for Schizophrenia
Inder Kaul, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
1,232 Total Patients Enrolled
4 Trials studying Schizophrenia
1,232 Patients Enrolled for Schizophrenia
Ronald Marcus, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
1,171 Total Patients Enrolled
1 Trials studying Schizophrenia
400 Patients Enrolled for Schizophrenia

Media Library

Xanomeline and Trospium Chloride Capsules Clinical Trial Eligibility Overview. Trial Name: NCT05304767 — Phase 3
Schizophrenia Research Study Groups: Drug: KarXT
Schizophrenia Clinical Trial 2023: Xanomeline and Trospium Chloride Capsules Highlights & Side Effects. Trial Name: NCT05304767 — Phase 3
Xanomeline and Trospium Chloride Capsules 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304767 — Phase 3

Frequently Asked Questions

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

Do Xanomeline and Trospium Chloride Capsules have any harmful side effects?

"Prior clinical data and multiple rounds of safety testing support the use of Xanomeline and Trospium Chloride Capsules, so it received a score of 3."

Answered by AI

Can patients that are 35 years or older participate in this test?

"The age restrictions for this trial are individuals who are 18 or older, and 55 or younger."

Answered by AI

Where are the medical facilities that are running this experiment?

"Currently, there are 14 sites administering this trial with more locations in Staten Island, Little Rock and Tamarac. If you are looking to enroll, try and select the clinic that is the most geographically convenient to you to cut down on travel time."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Adaptive Clinical Research, Inc.
Synexus Clinical Research
Collaborative Neuroscience Network
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried other drugs that don't work. I'm just trying to find something that helps.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Synexus Clinical Research: < 24 hours
Typically responds via
Phone Call
Email
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
2022. "An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05304767.
All > Schizophrenia
~128 spots leftby Feb 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top