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Completed

NCT Number: NCT06572449

Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

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Key information

Conditions

Schizophrenia Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0002, Los Alamitos, California, 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

  • Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
  • Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
  • Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
  • Willing and able to discontinue all antipsychotic medications prior to baseline visit.

Exclusion criteria

  • History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
  • Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
  • History of treatment resistance to schizophrenia medications.
  • History of allergy/hypersensitivity to KarXT.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: BMS-986510

Primary outcomes

  1. Number of Participants With TEAEs From First Dose to End of Study Follow up.

    Time frame: From first dose to end of study follow up (63 days)

    Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up.

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  2. Number of Participants With TEAEs at the End of Period 1 and Period 2.

    Time frame: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)

    Number of participants with TEAEs at the end of period 1 and period 2.

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

  3. Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.

    Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

    Number of participants with TEAEs at the end of period 1 and period 2.

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  4. Number of Participants With TEAEs Leading to Treatment Discontinuation.

    Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

    Number of participants with TEAEs leading to treatment discontinuation.

  5. Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.

    Time frame: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)

    The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.

Secondary outcomes

  1. Change From Baseline in PANSS Total Score, Positive Score and Negative Score

    Time frame: From first dose to end of treatment (56 days)

    The Positive and Negative Syndrome Scale (PANSS) assesses schizophrenia symptom severity using 30 items: 7 positive, 7 negative, and 16 general psychopathology scales. Each item is rated from 1 (absent) to 7 (extreme). Positive symptoms represent excesses or distortions of normal function (e.g., hallucinations, delusions), while negative symptoms reflect diminished function. The PANSS positive and negative scores each sum their respective 7 items, ranging from 7 to 49, with higher scores indicating greater severity. The PANSS Total Score sums all 30 items, ranging from 30 to 210, with higher scores reflecting worse overall symptom severity.

  2. Change From Baseline in Marder Factor Score.

    Time frame: From first dose to end of treatment (56 days)

    PANSS Marder factor score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale, with a total score ranging from 7 to 49. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Baseline is defined as the PANSS score at screening.

  3. Change From Baseline in CGI Severity Score

    Time frame: From first dose to end of treatment (56 days)

    Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness.

  4. Number of Participants With Spontaneously Reported AESIs

    Time frame: From first dose to end of study follow up (63 days)

    The AEs of special interest (AESIs) will be monitored and include symptomatic orthostasis, syncope(a transient loss of consciousness or fainting),and liver function test elevations as defined below. For SAE reporting requirements for events of liver injury.

  5. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: From first dose to end of study follow up (63 days)

    Number of participants with clinically significant changes in vital signs

  6. Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

    Time frame: From first dose to end of study follow up (63 days)

    Number of participants with clinically significant changes in clinical laboratory assessments

  7. Number of Participants With Clinically Significant Changes in 12-lead ECGs

    Time frame: From first dose to end of study follow up (63 days)

    Number of participants with clinically significant changes in 12-lead ECGs

  8. Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS

    Time frame: From first dose to end of study follow up (63 days)

    Number of participants who exhibited suicidal behavior as assessed by C-SSRS

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study title

A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Jun 22, 2026

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

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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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