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KarXT for Schizophrenia (ARISE Trial)

Phase 3
Recruiting
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 55 years at Screening
Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2
Timeline
Screening 30 days
Treatment 7 weeks
Follow Up week 6
Awards & highlights

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.

Who is the study for?
Adults aged 18-60 with schizophrenia, stable and not hospitalized for psychiatric issues in the last 8 weeks. They must be on certain antipsychotics without adequate symptom control, have a BMI of 18-40, and agree to use contraception if applicable. Excludes those with other primary disorders or severe substance abuse within the past year.Check my eligibility
What is being tested?
The trial tests KarXT (xanomeline-trospium combo) as an add-on to current antipsychotic treatment over six weeks. It's randomized and placebo-controlled, aiming to see if it better manages schizophrenia symptoms measured by PANSS Total Score compared to a placebo.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions associated with anticholinergic drugs like xanomeline and trospium such as dry mouth, constipation, blurred vision, urinary retention; plus any specific risks related to their combination.

ARISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I have been diagnosed with schizophrenia by a psychiatrist.
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I have been on the same dose of my schizophrenia medication for at least 8 weeks.
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I've tried an antipsychotic for 6 weeks without improvement.
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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.
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I have been on the same dose of my schizophrenia medication for at least 8 weeks.
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I've tried an antipsychotic for 6 weeks without improvement.
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I am between 18 and 59 years old.
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I can sign a consent form before any tests are done.
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I have been diagnosed with schizophrenia by a detailed psychiatric evaluation.
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I have been on the same dose of my current antipsychotic medication for at least 8 weeks.
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I have tried an antipsychotic for 6 weeks without improvement.
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My blood test shows I have antipsychotic medication in my system.
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I have severe symptoms like delusions or hallucinations.
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I can visit the clinic regularly and follow the study's instructions.
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I am using or willing to use effective birth control if I can have children.
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I am between 18 and 59 years old.
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I have been diagnosed with schizophrenia by a detailed psychiatric evaluation.
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I have been on the same dose of my antipsychotic medication for at least 8 weeks.
Select...
I've tried an antipsychotic for 6 weeks without improvement.
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I have severe symptoms like delusions or hallucinations.

ARISE Trial Timeline

Screening ~ 30 days
Treatment ~ 7 weeks
Follow Up ~week 6
This trial's timeline: 30 days for screening, 7 weeks for treatment, and week 6 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 6
Secondary outcome measures
Categorical response defined as the proportion of subjects achieving a ≥ 30% improvement in PANSS total score at Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
Change from Baseline in Personal Social Performance (PSP) at Week 6
+3 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%
Abdominal discomfort
6%
Diarrhoea
6%
Gastrooesophageal reflux disease
5%
Somnolence
5%
Anxiety
5%
Dry mouth
5%
Vision blurred
3%
Heart rate increased
3%
Abdominal pain
2%
Insomnia
2%
Orthostatic hypotension
2%
Agitation
2%
Back pain
2%
Suicidal ideation
2%
Salivary hypersecretion
1%
Toothache
1%
Psychotic disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
KarXT

ARISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: 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
3,006 Total Patients Enrolled
9 Trials studying Schizophrenia
1,926 Patients Enrolled for Schizophrenia
Bruce Kinon, MDStudy DirectorKaruna Therapeutics
1 Previous Clinical Trials
280 Total Patients Enrolled
1 Trials studying Schizophrenia
280 Patients Enrolled for Schizophrenia
Ronald Marcus, MDStudy DirectorKaruna Therapeutics
4 Previous Clinical Trials
1,051 Total Patients Enrolled
1 Trials studying Schizophrenia
280 Patients Enrolled for Schizophrenia

Media Library

Xanomeline and Trospium Chloride Capsules Clinical Trial Eligibility Overview. Trial Name: NCT05145413 — Phase 3
Schizophrenia Research Study Groups: Drug: KarXT, Placebo
Schizophrenia Clinical Trial 2023: Xanomeline and Trospium Chloride Capsules Highlights & Side Effects. Trial Name: NCT05145413 — Phase 3
Xanomeline and Trospium Chloride Capsules 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145413 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05145413 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
1
2
What site did they apply to?
Synexus Clinical Research US, Inc.
Adaptive Clinical Research, Inc.
Richmond Behavioral Associates
Other

Why did patients apply to this trial?

I've tried others drug that don't work. I have schizophrenia. I am willing to try almost anything!
PatientReceived no prior treatments
I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Synexus Clinical Research US, Inc.: < 24 hours
  2. University Hills Clinical Research: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~71 spots leftby Oct 2024