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Trial ID CN012-0021  |   NCT07424404

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 5-17
    Age Range
  • 28
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

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Key Eligibility Criteria

Inclusion Criteria

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  • Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

    Exclusion Criteria

    Exclusion Criteria Icon
    • Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
      1. Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
        1. Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
          Additional Information *
          • Other protocol-defined Inclusion/Exclusion criteria apply.

            Treatment Options

            Study Arms

            ASSIGNED INTERVENTION

            Study Arms

            Experimental: Administration of KarXT for Autism-related Irritability

            ASSIGNED INTERVENTION
            • Drug: KarXT

            Study Arms

            Experimental: Administration of KarXT for Schizophrenia

            ASSIGNED INTERVENTION
            • Drug: KarXT
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