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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initial dose through 7 days after the final dose (up to 53 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial dose through 7 days after the final dose (up to 53 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of 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 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 moreSide effects data
From 2022 Phase 3 trial • 252 Patients • NCT0465916121%
Constipation
19%
Dyspepsia
19%
Nausea
14%
Vomiting
13%
Headache
10%
Hypertension
9%
Dizziness
6%
Abdominal discomfort
6%
Gastrooesophageal reflux disease
6%
Diarrhoea
5%
Dry mouth
5%
Anxiety
5%
Somnolence
5%
Vision blurred
3%
Abdominal pain
3%
Heart rate increased
2%
Insomnia
2%
Suicidal ideation
2%
Orthostatic hypotension
2%
Agitation
2%
Salivary hypersecretion
2%
Back pain
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
~1420
Find a Location
Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
15 Previous Clinical Trials
3,834 Total Patients Enrolled
10 Trials studying Schizophrenia
2,270 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history or show a high likelihood of behaving in a violent or destructive manner.The doctor will evaluate if you are at risk of having thoughts of hurting yourself during the study.
Research Study Groups:
This trial has the following groups:- Group 1: KarXT
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT04659174 — Phase 3
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