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A study to evaluate the efficacy and safety of trospium chloride and xanomeline tartrate for the treatment of schizophrenia in adolescents aged 13 to 17 years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is designed to evaluate the efficacy and safety of KarXT for the treatment of Schizophrenia in adolescents. Schizophrenia is a mental health disorder that can affect how a person thinks, feels, and behaves. The medication being tested, KarXT, is an oral capsule containing two active substances, trospium chloride and xanomeline tartrate.

Participants in this research will be assigned to receive either KarXT or a placebo. This is a randomized study, meaning participants are placed into groups by chance, and it is double-blind, which means neither the participants nor the researchers know which treatment is being given. During the study, the way the medication affects the symptoms of the condition will be observed over a period of several weeks.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    Participation begins with the administration of either KarXT or a placebo, which is a dummy pill containing no active medicine.

    KarXT is provided in capsule form and is taken by mouth (oral).

    The specific dosage of KarXT will be determined as part of the study protocol using the active substances trospium chloride and xanomeline tartrate.

  2. Step 2

    Evaluation of symptoms

    At week 5, the effectiveness of the medication is measured by checking the change in the positive and negative syndrome scale (PANSS) total score. the PANSS is a tool used to assess the severity of schizophrenia symptoms.

    At week 5, the clinical global impression - severity (CGI-S) score is also evaluated. this is a scale used to rate how much the symptoms of the condition affect daily life.

Who can join the trial?

6 criteria

  • You must be between 13 and 17 years old at the time you sign the informed consent form, which is a document that explains all the details of the study before you agree to join.
  • A legally acceptable representative, such as a parent or legal guardian, must sign and date the informed consent form.
  • You must have a formal diagnosis of schizophrenia, which is a mental health condition, and be experiencing psychosis, which means having a loss of contact with reality, such as seeing or hearing things that are not there.
  • Female participants must have a negative pregnancy test using a highly sensitive serum test (a blood test) during the screening process and a urine test within 24 hours before starting the study medication.
  • You must agree to use highly effective contraception, which refers to methods used to prevent pregnancy, as described in the study documents.
  • You must live in a stable living condition and be able to stay in the same place for the entire time the study lasts.

Who cannot join the trial?

11 criteria

  • People who have been diagnosed with any mental health disorder other than schizophrenia in the last 12 months, such as major depressive disorder (long-term feelings of sadness), bipolar disorder (extreme mood swings), obsessive compulsive disorder (unwanted repetitive thoughts or actions), or post-traumatic stress disorder (stress following a traumatic event).
  • People who have substance use disorders, which means having trouble controlling the use of drugs or alcohol, excluding nicotine or caffeine.
  • People who are unable to swallow pills or capsules or cannot tolerate taking medicine by mouth.
  • People with serious long-term health problems involving the cardiovascular system (heart and blood vessels), pulmonary system (lungs), hepatic system (liver), renal system (kidneys), hematologic system (blood), gastrointestinal system (stomach and intestines), endocrine system (hormones), immunologic system (immune system), dermatologic system (skin), neurologic system (brain and nerves), or oncologic disease (cancer).
  • People with any brain or nerve disorders, except for Tourette’s Syndrome (a condition involving repetitive movements or sounds).
  • People with uncontrolled diabetes or blood sugar levels that are too high or too low during testing.
  • People who have epilepsy (a disorder causing seizures), a history of seizures (sudden electrical disturbances in the brain), severe head trauma (serious injury to the head), or a stroke (when blood flow to the brain is interrupted).
  • People who have a high risk of hurting themselves, attempting suicide (trying to end their own life), or acting violently toward others.
  • People who have taken the study medicine, KarXT, before.
  • People who have had bad reactions or side effects from xanomeline or trospium chloride (the specific ingredients in the study medicine).
  • People who have unusual or concerning results from laboratory tests, such as blood or urine tests, during the first visit.
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Investigated drugs

KarXT is an oral capsule being tested to see if it can help reduce the symptoms of schizophrenia in teenagers. It contains two active components that work together to target specific receptors in the brain to manage the condition.

What is already known about the treatment

KarXT - This medication is taken as a capsule by mouth and is currently being studied in clinical trials for its potential to treat schizophrenia. It belongs to a new class of drugs that works by targeting specific receptors in the brain, specifically the muscarinic receptors, to help balance chemical signals. The treatment combines two substances where one helps manage brain activity while the other prevents certain side effects from affecting the rest of the body.

Investigated diseases

Schizophrenia - This is a long-term mental health condition that affects how a person thinks, feels, and behaves. It often involves experiences where the person perceives things that are not real or believes things that are not true. Symptoms may include disorganized thinking, unusual movements, or a lack of emotional expression. The condition typically develops gradually and can involve fluctuations in the severity of these symptoms over time. It can impact a person's ability to organize thoughts and interact with others.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523711-11-00Protocol codeCN0120020Estimated enrolment166 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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