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Cholinergic Agonist

Xanomeline and Trospium Chloride Capsules 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
Subject is aged 18 to 65 years, inclusive, at screening.
Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5
Awards & highlights

Study Summary

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

Eligible Conditions
  • Schizophrenia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Subjects must be aged 18 to 65 years in order to be screened.
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Subject is experiencing an increase in psychotic symptoms, which began less than 2 months ago.
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The patient needs to be hospitalized for this recent flare-up of psychotic symptoms.
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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.
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P2 is characterized by difficulties in organizing or understanding concepts

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Secondary outcome measures
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
+2 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%
Diarrhoea
6%
Abdominal discomfort
6%
Gastrooesophageal reflux disease
5%
Vision blurred
5%
Somnolence
5%
Anxiety
5%
Dry mouth
3%
Heart rate increased
3%
Abdominal pain
2%
Insomnia
2%
Orthostatic hypotension
2%
Agitation
2%
Suicidal ideation
2%
Back pain
2%
Salivary hypersecretion
1%
Toothache
1%
Psychotic disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
KarXT
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KarXTExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 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
3,150 Total Patients Enrolled
9 Trials studying Schizophrenia
2,070 Patients Enrolled for Schizophrenia
Inder Kaul, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
1,256 Total Patients Enrolled
4 Trials studying Schizophrenia
1,256 Patients Enrolled for Schizophrenia

Frequently Asked Questions

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

How many test subjects are needed for this experiment?

"Unfortunately, this study is not currently enrolling patients. The trial was first posted on April 6th 2021 and updated November 11th 2022. There are other trials related to schizophrenia that are recruiting 349 participants and 5 trials for Xanomeline and Trospium Chloride Capsules looking for willing enrollees."

Answered by AI

how many different medical facilities are hosting this research project?

"Patients can enroll at Larkin Behavioral Health Services in Hollywood, Florida, Collaborative Neuroscience Research, LLC. in Garden Grove, California, and CNS Network in Long Beach, Texas as well as 18 other locations."

Answered by AI

Does this trial have an age limit and, if so, what is it?

"The target enrollment for this clinical trial are individuals that are over 18 but have not yet reached 65 years old."

Answered by AI

Would I be able to qualify for this medical research program?

"We are looking for 246 individuals with schizophrenia that fall within the ages of 18-65. The following must also be met: needing hospitalization due to a recent relapse or exacerbation of psychotic symptoms (within 2 months of screening), being hospitalized for less than 2 weeks at the time of screening, and item 2 on the P2 scale."

Answered by AI

Do people experience many negative side effects from taking Xanomeline and Trospium Chloride Capsules?

"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so our team at Power rates the safety of Xanomeline and Trospium Chloride Capsules as a 3."

Answered by AI

Are Xanomeline and Trospium Chloride Capsules new medications?

"There are 5 ongoing clinical trials evaluating the efficacy of Xanomeline and Trospium Chloride Capsules. 4 of these trials have reached Phase 3. Although many of the trials are situated in Riverside, California, there are a total 159 locations running these clinical trials."

Answered by AI

Is it possible to sign up for this experiment at the moment?

"No, this particular study is not searching for new participants as of right now. However, it is worth noting that there are other 354 clinical trials actively recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Hassman Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
~65 spots leftby Mar 2025