KarXT for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new treatment called KarXT for managing schizophrenia symptoms in adolescents. Participants will receive either KarXT or a placebo (a substance with no active treatment) to compare results. Suitable candidates have been diagnosed with schizophrenia and are currently experiencing symptoms of psychosis (disconnection from reality). As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for schizophrenia.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that KarXT is likely to be safe for humans?
Research shows that KarXT is a promising treatment for schizophrenia with manageable side effects. Studies have found that KarXT, which combines xanomeline and trospium, is well tolerated by people with severe symptoms of schizophrenia. Research highlights that it significantly improves both the negative and positive symptoms of the condition.
Regarding safety, KarXT has been tested in adults with schizophrenia and is generally well tolerated, meaning its side effects are not severe for most patients. While specific side effects are not detailed, existing evidence supports its use in treating schizophrenia symptoms.
KarXT is currently in a Phase 3 trial, indicating it has shown safety in earlier trials and is now being tested on a larger group to confirm its safety and effectiveness. Overall, current research suggests that KarXT is a well-tolerated option for managing schizophrenia symptoms.12345Why do researchers think this study treatment might be promising for schizophrenia?
Most treatments for schizophrenia, like antipsychotics, work by balancing dopamine and serotonin in the brain. But KarXT is different; it targets the muscarinic receptors in the brain, which is a novel approach. Researchers are excited because this mechanism could lead to fewer side effects, like weight gain or sedation, common with traditional antipsychotics. Additionally, KarXT has a unique formulation that combines xanomeline, which targets muscarinic receptors, with trospium to reduce side effects, potentially offering a safer and more effective option for patients with schizophrenia.
What evidence suggests that KarXT might be an effective treatment for Schizophrenia?
Research has shown that KarXT, a combination of xanomeline and trospium, effectively treats schizophrenia. In this trial, participants will receive either KarXT or a placebo. Studies have found that KarXT reduces symptoms like hallucinations and delusions, common in acute psychosis. Importantly, data from several trials indicate that patients tolerate KarXT well, managing its side effects effectively. Additionally, KarXT targets specific brain areas linked to schizophrenia, which may explain its efficacy. Overall, these findings support its potential as a promising treatment for schizophrenia.26789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adolescents with schizophrenia, confirmed by specific diagnostic criteria and showing a certain level of symptom severity. Participants must not have other major psychiatric disorders within the last year or serious medical conditions like liver impairment, neurological disorders (except Tourette's Syndrome), or intellectual disability.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT or placebo for the treatment of schizophrenia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarXT
Trial Overview
The study tests KarXT against a placebo to see if it's effective and safe in treating schizophrenia symptoms in adolescents. Participants will be randomly assigned to receive either KarXT or an inactive substance that looks the same.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
KarXT for schizophrenia–effectiveness and value
Schizophrenia is a serious mental illness that affects about 3.9 million people in the United States and 24 million people worldwide.
KarXT for schizophrenia–effectiveness and value
Schizophrenia is a serious mental illness that affects about 3.9 million people in the United States and 24 million people worldwide.
Long-term treatment with KarXT was ...
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis ...
Efficacy and Safety of Xanomeline-Trospium Chloride in ...
Conclusions and Relevance Xanomeline-trospium was efficacious and well tolerated in people with schizophrenia experiencing acute psychosis.
Efficacy of KarXT on negative symptoms in acute ...
Data were pooled from the three pivotal trials of KarXT monotherapy in people with schizophrenia with an acute exacerbation of psychosis. All 3 studies used ...
Efficacy and Safety of the Muscarinic Receptor Agonist ...
KarXT offers significant improvements in both negative and positive symptoms of schizophrenia with a manageable safety profile.
NCT03697252 | A Study to Assess Safety and Efficacy of ...
The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
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icer.org
icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-treatment-for-schizophrenia/ICER Publishes Evidence Report on Treatment for ...
“Schizophrenia is a serious mental illness that affects how a person ... However, the only available data on the efficacy and side effect profile ...
Safety and tolerability of KarXT (xanomeline–trospium) in a ...
Despite evidence of antipsychotic efficacy in patients with psychosis associated with dementia as well as schizophrenia, the earlier clinical ...
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