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NCT Number: NCT07221877

A Study to Evaluate the Effect of KarXT on Urological Safety

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pillar Clinical Research- Little Rock, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
  • Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.
  • Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.

Exclusion criteria

  • Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
  • Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
  • Other protocol-defined Inclusion/Exclusion criteria apply

Treatment and study plan

Xanomeline/Trospium Chloride

Drug

Specified dose on specified days

Other names: KarXT, BMS-986510

Primary outcomes

  1. Change from baseline in voiding dynamics (Qmax) over time

    Time frame: Up to 12 months

  2. Change from baseline in post-void residual volume (PVR) over time

    Time frame: Up to 12 months

Secondary outcomes

  1. Number of participants with a change from baseline in urinalysis parameters over time

    Time frame: Up to 12 months

  2. Change from baseline in IPSS over time

    Time frame: Up to 12 months

  3. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 12 months

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 12 months

  5. Number of participants with Adverse Events (AEs)

    Time frame: Up to 12 months

  6. Number of participants with AEs of Special Interest (AESIs)

    Time frame: Up to 12 months

  7. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 12 months

  8. Number of participants with suicidal ideation or behavior

    Time frame: Up to 12 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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