A Study to Evaluate the Effect of KarXT on Urological Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-21

Study Completion Date

2027-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KarXT

Group Type EXPERIMENTAL

Xanomeline/trospium chloride

Intervention Type DRUG

Specified dose on specified days

Interventions

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Xanomeline/trospium chloride

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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KarXT BMS-986510

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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