KarXT for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the medication KarXT is processed in breast milk and blood. It targets healthy women who are breastfeeding. Participants must be at least four weeks postpartum, able to consistently produce breast milk, and willing to pump milk exclusively during the study. The research aims to ensure the safety and effectiveness of KarXT for breastfeeding mothers. As a Phase 4 trial, KarXT has already received FDA approval and proven effective, and this research helps to understand its benefits for more patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for this treatment?
Research has shown that KarXT, a treatment combining xanomeline and trospium, has generally been well tolerated in studies focusing on adults with schizophrenia. Reported side effects relate to the drug's interaction with certain brain receptors, suggesting these effects are predictable and manageable.
KarXT has undergone several trials, consistently demonstrating a safety profile that aligns with expectations. Although specific data on the new trial isn't available yet, its previous use in other conditions provides a reasonable indication of its safety for healthy individuals.12345Why are researchers enthusiastic about this study treatment?
Most treatments for mental health conditions like schizophrenia target neurotransmitters such as dopamine. But KarXT works differently, targeting muscarinic receptors in the brain. This novel mechanism may offer improvements in treating symptoms like hallucinations and cognitive issues without causing the typical side effects associated with current antipsychotics, such as weight gain or sedation. Researchers are excited about KarXT because it represents a fresh approach that could lead to better outcomes for patients.
What is the effectiveness track record for KarXT?
Research has shown that KarXT, a combination of xanomeline and trospium, is a promising treatment for schizophrenia. Studies have found that it can improve symptoms in people with this condition. Additionally, KarXT may cause less weight gain, potentially reducing the risk of metabolic issues like diabetes. Notably, KarXT is already approved for treating schizophrenia, as this trial is in Phase 4. Overall, evidence supports KarXT as an effective option for managing schizophrenia.46789
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 healthy lactating women who are currently breastfeeding. The study aims to understand how a drug called KarXT, which they will take orally, behaves in their body and breast milk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple oral administrations of KarXT to evaluate PK in breast milk and plasma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarXT
Trial Overview
The focus of the trial is on KarXT, a combination of xanomeline and trospium chloride. It's being given to see how much of it passes into breast milk and blood plasma after multiple doses.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karuna Therapeutics
Lead Sponsor
Citations
Effectiveness of KarXT (xanomeline-trospium) for cognitive ...
These findings suggest that KarXT may have a separable and meaningful impact on cognition, particularly among patients with cognitive impairment.
KarXT for schizophrenia–effectiveness and value
KarXT (Karuna Therapeutics) is an emerging treatment for schizophrenia, with a regulatory decision anticipated in September 2024.
NCT04659161 | A Study to Assess Efficacy and Safety of ...
The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) ...
Efficacy and Safety of Xanomeline-Trospium Chloride in ...
This randomized clinical trial evaluates the efficacy and safety of xanomeline-trospium chloride vs placebo in adults with schizophrenia.
5.
icer.org
icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-treatment-for-schizophrenia/ICER Publishes Evidence Report on Treatment for ...
KarXT was associated with significantly lower weight gain, which may translate into fewer cases of metabolic syndrome, diabetes, and ...
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.
Safety and tolerability of KarXT (xanomeline–trospium) in a ...
KarXT was generally well tolerated with an AE profile consistent with the activity of xanomeline–trospium at muscarinic receptors.
216158Orig1s000 - accessdata.fda.gov
... KarXT1) for the treatment of schizophrenia in adults. Cobenfy is a fixed-combination product containing two small molecules, xanomeline ...
Efficacy and safety of the muscarinic receptor agonist ...
The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.
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