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KarXT for Schizophrenia
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 252 Patients • NCT04659161Trial Design
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Who is running the clinical trial?
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- 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.
Frequently Asked Questions
Has the FDA given their okay to market and sell Xanomeline and Trospium Chloride Capsules?
"There is both pre-existing data supporting the safety of Xanomeline and Trospium Chloride Capsules as well as multiple rounds of testing, so it received a score of 3."
Who meets the enrollment criteria for this research project?
"This study is looking for 400 participants that have been diagnosed with schizophrenia and are aged 18-65. Most importantly, applicants need to meet the following criteria: They must be aged 18-65 years old at screening, they must be able to provide informed consent, they must be fluent in the language of the ICF to consent, they have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on DSM-5 criteria and confirmed by MINI version 7.0.2., they have not required psychiatric hospitalization or acute crisis intervention within 8 weeks of screening and are psychiatrically stable in the opinion of the investigator.,"
Does the age limit for this research extend to individuals under twenty years old?
"The patients that this study can include are restricted to those aged 18-65. There are 47 other trials for people below the age of majority and 178 studies for senior citizens."
Is this trial widely available to patients in the United States?
"There are 54 total locations for this study, with 3 primary sites. They are Suburban Research Associates in Media, Pennsylvania, Siyan Clinical Research in Santa Rosa, California, and Excell Research Inc in Oceanside, Ohio."
Could you walk me through other scientific research that has used Xanomeline and Trospium Chloride Capsules?
"There are a total of 5 clinical trials involving Xanomeline and Trospium Chloride Capsules with 4 being in Phase 3. Many of these medical studies will soon be completed as 159 different centres across the globe are testing this medication."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- InSite Clinical Research, LLC: < 48 hours
Average response time
- < 2 Days
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