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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.
At Day 0, subject will have been off lithium therapy for at least 2 weeks and must have discontinued all oral antipsychotic medications.
Must not have
Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the past 12 months or having received clozapine within the past 3 years
Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before 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

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 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 am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have schizophrenia and haven't responded to 2 different treatments in the last year, or I've been on clozapine in the past 3 years.
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I have been hospitalized for psychiatric reasons for over 30 days in the last 6 months.
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I have HIV, liver issues, or a liver infection.
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I have not been diagnosed with a mental health disorder other than schizophrenia in the last year.
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I have previously been treated with KarXT.
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I have a history or high risk of problems with bladder, stomach emptying, or a specific eye condition.
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I have no significant abnormal findings in my recent medical exams.
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I have had serious constipation or irritable bowel syndrome in the last 6 months.

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%
Nausea
19%
Dyspepsia
14%
Vomiting
13%
Headache
10%
Hypertension
9%
Dizziness
6%
Abdominal discomfort
6%
Diarrhoea
6%
Gastrooesophageal reflux disease
5%
Vision blurred
5%
Somnolence
5%
Dry mouth
5%
Anxiety
3%
Abdominal pain
3%
Heart rate increased
2%
Insomnia
2%
Back pain
2%
Suicidal ideation
2%
Orthostatic hypotension
2%
Salivary hypersecretion
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily target dopamine and serotonin receptors to manage symptoms. Traditional antipsychotics block dopamine D2 receptors to reduce positive symptoms, while second-generation antipsychotics also target serotonin receptors to help with negative symptoms and cognitive deficits. KarXT, combining xanomeline (a muscarinic receptor agonist) and trospium chloride (a muscarinic receptor antagonist), modulates the cholinergic system, potentially improving cognitive function, which is a significant unmet need in schizophrenia treatment.
Adverse effects of antipsychotic agents. Do newer agents offer advantages?Clozapine's multiple cellular mechanisms: What do we know after more than fifty years? A systematic review and critical assessment of translational mechanisms relevant for innovative strategies in treatment-resistant schizophrenia.Discovery of Procognitive Antipsychotics by Combining Muscarinic M<sub>1</sub> Receptor Structure-Activity Relationship with Systems Response Profiles in Zebrafish Larvae.

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
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,536 Previous Clinical Trials
3,375,239 Total Patients Enrolled
12 Trials studying Schizophrenia
3,510 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
~139 spots leftby Jul 2025
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