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Long-term safety study of trospium chloride and xanomeline tartrate combination (KarXT) for treatment of manic episodes in adults with Bipolar I Disorder

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What is this trial about?

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

This study focuses on the long-term safety evaluation of KarXT in people with Bipolar-I Disorder who experience mania or mania with mixed features. Mania is a condition where a person experiences unusually high energy levels, reduced need for sleep, and sometimes impulsive or risky behavior. The medication being studied, KarXT, contains two active substances: trospium chloride and xanomeline tartrate, and is taken as oral capsules.

The purpose of this research is to determine if KarXT is safe and well-tolerated when used for an extended period by people with manic episodes related to Bipolar-I Disorder. The study will monitor how participants respond to the treatment over time and track any side effects that may occur during the treatment period.

During this open-label extension study, all participants will receive the study medication KarXT. The treatment period will last for approximately 51 weeks, during which participants will take the medication daily. Throughout the study, healthcare providers will regularly monitor participants' health and well-being through various assessments and check-ups to ensure their safety.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    Your age must be between 18 and 65 years

    You must have a confirmed diagnosis of Bipolar-I disorder

    You will complete two assessments to evaluate your symptoms and daily functioning

    If you are taking psychiatric medications, they will be gradually discontinued over 14 days before starting the study medication

  2. Step 2

    Beginning treatment

    You will start taking KarXT medication

    The medication comes in capsule form and is taken by mouth

    The medication contains two active substances: trospium chloride and xanomeline tartrate

  3. Step 3

    Ongoing monitoring

    Your health will be regularly monitored throughout the study period

    Medical staff will track any side effects you may experience

    You will complete the Columbia Suicide Severity Rating Scale questionnaire periodically

    Various safety measurements will be taken during your visits

  4. Step 4

    Study duration

    The study begins on September 15, 2025

    The study continues until June 13, 2028

    This is a long-term safety study to evaluate how well the medication is tolerated over time

Who can join the trial?

7 criteria

  • You must be between 18 and 65 years old
  • You must have been diagnosed with Bipolar-I disorder (a mental health condition that causes episodes of extreme mood swings)
  • You must be willing to gradually stop taking your current psychiatric medications under medical supervision within 14 days before starting the study medication
  • You must achieve certain minimum scores on two assessment questionnaires that evaluate your:
    • Current symptoms
    • Daily functioning and well-being
    • Both men and women can participate in the study
    • You must be able to understand and provide informed consent to participate in the research

Who cannot join the trial?

14 criteria

  • Presence of any psychiatric disorder other than Bipolar-I Disorder that is the primary focus of treatment
  • History of substance abuse or dependency within the past 6 months
  • Any significant medical condition that could affect the safety of the participant
  • Current use of medications that could interact with the study drug
  • Pregnancy or breastfeeding
  • History of severe allergic reactions to medications
  • Participation in another clinical trial within the past 30 days
  • Inability to provide informed consent
  • History of not following medical treatment plans
  • Any condition that could interfere with the absorption of oral medication
  • History of suicidal behavior or current suicidal thoughts
  • Unstable medical conditions that require frequent medication changes
  • History of severe heart, liver, or kidney problems
  • Use of prohibited medications within specified timeframes before the study
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Investigated drugs

KarXT is an investigational medication being studied for the treatment of mania or mixed manic episodes in people with Bipolar I Disorder. It is designed to help manage manic symptoms in patients with bipolar disorder. The medication is being tested in a long-term safety study to understand how well patients tolerate it over an extended period of time.

What is already known about the treatment

KarXT – An investigational medication being studied in clinical trials for the treatment of mania or mania with mixed features in Bipolar-I Disorder (BP-I). This novel therapeutic agent is currently undergoing Phase 3 clinical trials to assess its long-term safety and tolerability in patients with bipolar mania. While the specific form of administration is not detailed in the source data, KarXT represents a new approach to treating manic episodes in bipolar disorder, with researchers evaluating its safety profile through extended observation periods. The medication's therapeutic focus is specifically targeted at managing manic symptoms and mixed features associated with Bipolar-I Disorder, though its precise molecular mechanism of action is not specified in the provided clinical trial information.

Investigated diseases

Bipolar I Disorder - A mental health condition characterized by alternating episodes of mania and depression. During manic episodes, a person experiences unusually elevated mood, increased energy, reduced need for sleep, and may engage in risky behaviors. Manic episodes can also include racing thoughts, rapid speech, and inflated self-esteem. When mixed features are present, symptoms of both mania and depression occur simultaneously. Mixed features may include high energy and activity levels combined with feelings of sadness or hopelessness. The episodes typically last for several days to weeks.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520259-26-00Protocol codeCN012-0038Estimated enrolment431 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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