Xanomeline and Trospium Chloride Capsules for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Schizophrenia+1 More
Xanomeline and Trospium Chloride Capsules - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called KarXT may help reduce symptoms of schizophrenia.

Eligible Conditions
  • Schizophrenia
  • Psychotic Disorders

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Week 5

Week 5
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5
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 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Clinical Global Impression - Severity (CGI-S) Score at Week 5
Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 5

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

KarXT
17%Constipation
17%Nausea
9%Dry mouth
9%Dyspepsia
9%Vomiting
7%Headache
6%Somnolence
3%Dizziness
3%Akathisia
3%Weight increased
3%Tachycardia
2%Decreased appetite
2%Agitation
2%Hyperhidrosis
2%Insomnia
2%Sedation
2%Diarrhoea
2%Gamma-Glutamyltransferase increased
1%Psychotic disorder
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03697252) in the KarXT ARM group. Side effects include: Constipation with 17%, Nausea with 17%, Dry mouth with 9%, Dyspepsia with 9%, Vomiting with 9%.

Trial Design

2 Treatment Groups

KarXT
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

246 Total Participants · 2 Treatment Groups

Primary Treatment: Xanomeline and Trospium Chloride Capsules · Has Placebo Group · Phase 3

KarXT
Drug
Experimental Group · 1 Intervention: Xanomeline and Trospium Chloride Capsules · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trospium
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 5

Who is running the clinical trial?

Karuna TherapeuticsLead Sponsor
8 Previous Clinical Trials
2,314 Total Patients Enrolled
7 Trials studying Schizophrenia
1,934 Patients Enrolled for Schizophrenia
Inder Kaul, MDStudy DirectorKaruna Therapeutics
3 Previous Clinical Trials
1,002 Total Patients Enrolled
3 Trials studying Schizophrenia
1,002 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The subject has been diagnosed with schizophrenia based on the DSM-5 criteria and confirmed by the MINI.
Subject is experiencing an increase in psychotic symptoms, which began less than 2 months ago.
The patient needs to be hospitalized for this recent flare-up of psychotic symptoms.
Subjects must be aged 18 to 65 years in order to be screened.
Subject has the ability to make decisions that are informed.
Before any study assessments are conducted, a signed informed consent form must be provided.
and provide input on research A person must be able to fluently communicate in English or the local language in order to consent to and provide input for research.
If an individual is already an inpatient, and has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening, they are eligible for the study.
P1 is a delusion
P2 is characterized by difficulties in organizing or understanding concepts

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hassman Research Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%