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Cholinergic 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
At the time of screening, or at any time within the 30 days prior to screening, the subject must have received an oral antipsychotic medication daily at a dose and frequency consistent with the drug label.
Subject is aged 18 to 65 years at screening.
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 testing the long-term safety and efficacy of a new drug, KarXT, for people with schizophrenia. The drug is a combination of xanomeline and trospium chloride, and will be taken twice daily for up to 52 weeks. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and characterize the pharmacokinetics of xanomeline and trospium after administration of KarXT.

Who is the study for?
Adults aged 18-65 with schizophrenia, stable and not hospitalized for psychiatric reasons in the last 8 weeks. They must have a BMI of 18-40, be on oral antipsychotic medication, and can consent to the study. Women of childbearing age and men with partners of childbearing potential must use contraception.Check my eligibility
What is being tested?
The trial is testing KarXT (xanomeline-trospium) capsules over a period of one year to see how safe and effective they are for long-term treatment of schizophrenia in adults who meet specific health criteria.See study design
What are the potential side effects?
Potential side effects may include digestive issues like constipation or irritable bowel syndrome, urinary retention problems, dry mouth due to reduced saliva production, blurred vision or eye discomfort if prone to narrow-angle glaucoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking an oral antipsychotic medication as prescribed for the last 30 days.
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I am between 18 and 65 years old.
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I haven't taken long-acting antipsychotic injections for the required time before Day 0.
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I stopped taking lithium and all antipsychotic medications 2 weeks ago.
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I have been diagnosed with schizophrenia by a psychiatrist.
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I have been diagnosed with schizophrenia by a psychiatrist.
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I am able to understand and agree to the study's procedures and risks.
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I am able to understand and agree to the study's procedures and risks.
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I am between 18 and 65 years old.
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My doctor thinks it's safe for me to switch to a new experimental treatment.

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 PANSS Negative Marder Factor Score
Change From Baseline in PANSS Negative Score at Week 52
+5 more

Side effects data

From 2022 Phase 3 trial • 252 Patients • NCT04659161
21%
Constipation
19%
Dyspepsia
19%
Nausea
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%
Agitation
2%
Suicidal ideation
2%
Salivary hypersecretion
2%
Insomnia
2%
Orthostatic hypotension
2%
Back pain
1%
Toothache
1%
Psychotic disorder
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
2,838 Total Patients Enrolled
9 Trials studying Schizophrenia
1,758 Patients Enrolled for Schizophrenia
Inder Kaul, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
944 Total Patients Enrolled
4 Trials studying Schizophrenia
944 Patients Enrolled for Schizophrenia

Media Library

KarXT (Cholinergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04820309 — Phase 3

Frequently Asked Questions

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

Has the FDA given their okay to market and sell Xanomeline and Trospium Chloride Capsules?

"There is both pre-existing data supporting the safety of Xanomeline and Trospium Chloride Capsules as well as multiple rounds of testing, so it received a score of 3."

Answered by AI

Who meets the enrollment criteria for this research project?

"This study is looking for 400 participants that have been diagnosed with schizophrenia and are aged 18-65. Most importantly, applicants need to meet the following criteria: They must be aged 18-65 years old at screening, they must be able to provide informed consent, they must be fluent in the language of the ICF to consent, they have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on DSM-5 criteria and confirmed by MINI version 7.0.2., they have not required psychiatric hospitalization or acute crisis intervention within 8 weeks of screening and are psychiatrically stable in the opinion of the investigator.,"

Answered by AI

Does the age limit for this research extend to individuals under twenty years old?

"The patients that this study can include are restricted to those aged 18-65. There are 47 other trials for people below the age of majority and 178 studies for senior citizens."

Answered by AI

Is this trial widely available to patients in the United States?

"There are 54 total locations for this study, with 3 primary sites. They are Suburban Research Associates in Media, Pennsylvania, Siyan Clinical Research in Santa Rosa, California, and Excell Research Inc in Oceanside, Ohio."

Answered by AI

Could you walk me through other scientific research that has used Xanomeline and Trospium Chloride Capsules?

"There are a total of 5 clinical trials involving Xanomeline and Trospium Chloride Capsules with 4 being in Phase 3. Many of these medical studies will soon be completed as 159 different centres across the globe are testing this medication."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
What site did they apply to?
Behavioral Clinical Research, Inc.
Louisiana Clinical Research
InSite Clinical Research, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

I qualified with the diagnosis. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. InSite Clinical Research, LLC: < 48 hours
~16 spots leftby Jun 2024