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Trial ID CN012-0006  |   NCT07686263

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18-65
    Age Range
  • 44
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

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Key Eligibility Criteria

Inclusion Criteria

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  • Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
    1. Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
      1. Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
        1. Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution)
          1. Participant must have a CGI-S score of ≥ 4 at screening and Day -1
            1. Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

              Exclusion Criteria

              Exclusion Criteria Icon
              • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
                1. Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
                  1. Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
                    1. Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
                      1. Participant must not have a history of treatment resistance to schizophrenia medications
                        1. Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
                          Additional Information *
                          • Other protocol-defined Inclusion/Exclusion criteria apply.

                            Treatment Options

                            Study Arms

                            ASSIGNED INTERVENTION

                            Study Arms

                            Experimental: KarXT

                            ASSIGNED INTERVENTION

                            Study Arms

                            Placebo Comparator: Placebo

                            ASSIGNED INTERVENTION
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