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ARISE Trial Summary
This trial will test the effectiveness of a new medication, KarXT, for people with schizophrenia who haven't responded well to other treatments. The study will last 6 weeks and will compare KarXT to a placebo. The primary objective is to measure the effect of KarXT on symptoms of schizophrenia using the PANSS scale.
ARISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARISE Trial Timeline
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 • NCT04659161ARISE Trial Design
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- I have previously been treated with KarXT.I have been on the same dose of my current antipsychotic medication for at least 8 weeks.I have been on the same dose of my schizophrenia medication for at least 8 weeks.I've tried an antipsychotic for 6 weeks without improvement.I can visit the clinic regularly and follow the study's instructions.I am diagnosed with schizophreniform or experiencing my first schizophrenia episode.I cannot stop taking a medication that is not allowed in the study.I can visit the clinic regularly and follow the study's instructions.My blood test shows I have antipsychotic medication in my system.I have had side effects from xanomeline or trospium.I do not have severe health issues that could risk my safety in the study.I have not taken certain mental health medications recently, except for emergency anxiety meds.I am not currently taking olanzapine, quetiapine, or haloperidol for my condition.I have been taking Mirtazapine for sleep for at least 8 weeks.I have been on the same dose of my antipsychotic medication for at least 8 weeks.I am willing to use effective birth control during and after the study.Your weight must be within a certain range based on your height, called the Body Mass Index (BMI).I have been on the same dose of my schizophrenia medication for at least 8 weeks.I have had irritable bowel syndrome or serious constipation in the last 6 months.I have detectable antipsychotic medication levels from my first visit.I can sign a consent form before any tests are done.I have been diagnosed with schizophrenia by a detailed psychiatric evaluation.I have severe symptoms like delusions or hallucinations.I have schizophrenia and haven't improved after trying two different medications for at least 6 weeks each, or I've tried clozapine.I haven't been hospitalized or had a crisis due to mental health in the last 8 weeks and am stable on my current antipsychotic medication.I am between 18 and 59 years old.I can sign a consent form before any tests are done.Your symptoms, as measured by a test called PANSS, should not improve too much between the first and third visits.I have been diagnosed with schizophrenia by a psychiatrist.I am between 18 and 55 years old.I have no significant abnormal findings in my recent medical checks.I do not have HIV, cirrhosis, liver cancer, or active liver infections.I've tried an antipsychotic for 6 weeks without improvement.I am using or willing to use effective birth control if I can have children.I have tried an antipsychotic for 6 weeks without improvement.I have been diagnosed with schizophrenia by a detailed psychiatric evaluation.I have severe symptoms like delusions or hallucinations.I have not been diagnosed with a mental health disorder other than schizophrenia in the last year.I have been on a stable dose of SSRIs or SNRIs for at least 8 weeks.I am between 18 and 59 years old.I've tried an antipsychotic for 6 weeks without improvement.
- Group 1: Drug: KarXT
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 30 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 7 Weeks
- 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
Are there negative side-effects to taking Xanomeline and Trospium Chloride Capsules?
"Xanomeline and Trospium Chloride Capsules have both undergone Phase 3 clinical trials, meaning that there is some data supporting their efficacy and multiple rounds of data supporting their safety. Our team at Power estimates that they are safe to use, with a score of 3 on our scale."
Are there any patients currently needed for this clinical trial?
"Yes, the information available on clinicaltrials.gov confirms that this trial is open and recruiting patients. The details of the study indicate that it was first posted on November 12th, 2021 and last updated on November 3rd, 2022. This trial has plans to admit 400 total participants at 26 different sites."
Are Xanomeline and Trospium Chloride Capsules new to the medical field?
"There are currently 5 clinical trials involving Xanomeline and Trospium Chloride Capsules with 4 of them being in Phase 3. Although many research studies regarding these drugs are based in Riverside, California, there are a total of 159 locations running these sorts of trials."
Does this experimental treatment program exclude people who are over 25 years old?
"According to the age requirements set out in this trial's inclusion criteria, patients must be between 18-55 years old."
How many individuals are currently enrolled in this research project?
"Correct, the clinicaltrials.gov website has this trial listed as currently recruiting. The 400 participants are needed at 26 different locations and the trial was originally posted on 12/11/2021 with a most recent update of 3/11/2022."
Could I join the ranks of this clinical trial's participants?
"This trial, which seeks around 400 participants, is looking for individuals that have been diagnosed with schizophrenia and are between 18-55 years old."
At how many different facilities is this research being conducted?
"26 different hospitals or clinics are participating in this trial, with some notable locations being Santa Ana, Saint Louis and Overland Park. It would be best to choose a location close to you to limit the amount of travel needed."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Synexus Clinical Research US, Inc.: < 24 hours
- University Hills Clinical Research: < 48 hours
Typically responds via
Average response time
- < 2 Days
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