Study of KarXT (trospium chloride and xanomeline tartrate) in patients with inadequately controlled schizophrenia symptoms

1 1

What is this study about?

This study focuses on people with schizophrenia who still experience symptoms despite taking their current medication. The research examines a new drug called KarXT, which contains two active substances: trospium chloride and xanomeline tartrate. KarXT will be tested as an additional treatment alongside existing medications for schizophrenia.

The purpose of this research is to determine if KarXT, when added to current schizophrenia treatment, can help reduce symptoms better than placebo. During the study, participants will continue taking their regular schizophrenia medication while also receiving either KarXT capsules or placebo capsules. The medication will be taken by mouth.

The study will last 6 weeks, during which the effectiveness of KarXT will be measured by tracking changes in schizophrenia symptoms. Throughout the study, participants will need to visit the clinic regularly for check-ups. The medication dose may be adjusted during the study period, with the highest possible daily dose being 310 milligrams.

1 Initial evaluation

Your eligibility for the study will be assessed based on specific criteria, including age (18-65 years), current symptoms, and existing treatment regimen

You must have been taking a stable dose of one specific antipsychotic medication (risperidone, paliperidone, aripiprazole, ziprasidone, lurasidone, or cariprazine) for at least 8 weeks

Your PANSS total score (a measure of schizophrenia symptoms) must be 70 or higher

2 Study medication period

The study will last 6 weeks

You will receive either KarXT capsules or placebo capsules (inactive substance) to take by mouth

You will continue taking your current antipsychotic medication throughout the study

Blood tests will be performed to confirm the presence of your regular antipsychotic medication in your system

3 Regular assessments

Your symptoms will be evaluated using the PANSS scale (measures schizophrenia symptoms)

Your overall illness severity will be assessed using the CGI-S scale (measures illness severity)

Your daily functioning will be evaluated using the PSP scale (measures personal and social performance)

These assessments will occur throughout the study, with final measurements taken at week 6

4 Study completion

The final evaluation will occur at week 6

The main goal is to measure the change in your PANSS total score from the beginning to the end of the study

Additional measurements will include changes in your daily functioning and overall illness severity

Who Can Join the Study?

Age between 18 and 65 years at the time of study entry
Must have a confirmed diagnosis of schizophrenia based on medical evaluation and confirmed through specialized psychiatric interview
Currently taking one of these medications at a stable dose for at least 8 weeks: risperidone, paliperidone, aripiprazole, ziprasidone, lurasidone, or cariprazine
Body Mass Index (BMI) must be between 18 and 40
Must have a stable living situation
Must have a reliable support person who can help with study activities
Must be able to visit the clinic regularly as an outpatient and follow study instructions
Must be able to understand and sign the informed consent form
Must have certain levels of symptoms as measured by specialized assessment tools (PANSS score of 70 or higher and CGI-S score of 4 or higher)
Must have detectable levels of current antipsychotic medication in their system
Must not have been hospitalized for psychiatric reasons or needed crisis intervention in the past 8 weeks
For women who can become pregnant and men with partners who can become pregnant: must agree to use effective birth control during the study and for 30 days after

Who Cannot Join the Study?

Current diagnosis of substance use disorder (addiction to drugs or alcohol) within the past 6 months
History of treatment-resistant schizophrenia (condition not improving with at least 2 different antipsychotic medications)
Presence of severe depression or thoughts of self-harm
Significant heart problems or abnormal heart rhythm
Unstable medical conditions that could affect study participation
Use of medications that could interact with the study drug
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
History of serious allergic reactions to similar medications
Inability to follow study procedures or provide informed consent
Severe cognitive impairment (significant problems with memory or thinking) that could interfere with assessments
History of violence or aggressive behavior in the past 6 months
Significant abnormal laboratory test results
Use of certain prohibited medications within 5 half-lives or 14 days before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Asclepius Medical Center OOD	Dupnitsa	Bulgaria
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET	Cherven Bryag	Bulgaria
State Psychiatric Hospital Sv. Ivan Rilski – Novi Iskar	Novi Iskar	Bulgaria
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Medical Center Mentalcare Ltd.	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD	Kazanlak	Bulgaria
Mgzrnap Chykee Vjf Ovn	Targovishte	Bulgaria
Mfgwsxi Ctyfob Aoflttess Excl	Sofia	Bulgaria
Mtejgh Hzfzjt Cxyabb Spcew Ekag	Sofia	Bulgaria
Cjquqt Fdv Mtgugv Hqrvyo Vcgszo Elkh	Vratsa	Bulgaria
Mdygnhh Cghihk Marrmshbil Palhzq Orb	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	20.12.2022

Trial locations

Investigated drugs:

KarXT is an investigational medication being studied as an add-on treatment for people with schizophrenia whose symptoms are not adequately controlled by their current medications. This medication works differently from existing antipsychotic treatments and aims to help reduce both positive symptoms (such as hallucinations and delusions) and negative symptoms (such as lack of motivation and social withdrawal) of schizophrenia.

Investigated diseases:

Schizophrenia

Schizophrenia – A chronic mental disorder that affects how a person thinks, feels, and behaves. It typically appears in late teens or early adulthood and is characterized by a combination of hallucinations, delusions, and disordered thinking and behavior. The condition often includes both positive symptoms (such as hearing voices or having false beliefs) and negative symptoms (such as reduced emotional expression or lack of motivation). People with schizophrenia may experience difficulties with memory, concentration, and social interactions. The condition varies in severity and presentation from person to person, with symptoms typically developing gradually over time.

Trial ID:

2024-510770-25-00

Protocol code:

KAR-012

NCT ID:

NCT05145413

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of KarXT (trospium chloride and xanomeline tartrate) in patients with inadequately controlled schizophrenia symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?