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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 first dose to end of study (up to approximately 53 weeks)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of KarXT, a combination of two drugs, in patients with schizophrenia. The medication aims to improve symptoms while minimizing side effects. KarXT, a combination of xanomeline and trospium, has shown positive results in reducing both positive and negative symptoms of schizophrenia in earlier studies.

Eligible Conditions
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to end of study (up to approximately 53 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to end of study (up to approximately 53 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary study objectives
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 52
Change From Baseline in PANSS Negative Marder Factor Score at Week 52
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%
Dyspepsia
19%
Nausea
14%
Vomiting
13%
Headache
10%
Hypertension
9%
Dizziness
6%
Abdominal discomfort
6%
Gastrooesophageal reflux disease
6%
Diarrhoea
5%
Anxiety
5%
Dry mouth
5%
Somnolence
5%
Vision blurred
3%
Abdominal pain
3%
Heart rate increased
2%
Orthostatic hypotension
2%
Insomnia
2%
Suicidal ideation
2%
Agitation
2%
Salivary hypersecretion
2%
Back pain
1%
Psychotic disorder
1%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
KarXT
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1410

Find a Location

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
16 Previous Clinical Trials
3,882 Total Patients Enrolled
10 Trials studying Schizophrenia
2,230 Patients Enrolled for Schizophrenia
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,449 Total Patients Enrolled
15 Trials studying Schizophrenia
4,538 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
~31 spots leftby Dec 2025
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