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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CN012-0020  |   NCT07288567

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents

Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 13-17
  • 20
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

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Centro de reclutamiento más cercano

Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
    1. PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
      1. Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).

        Criterios de exclusión

        Criterios de exclusión Icon
        :
        • Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
          1. History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, 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.
            1. All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
              1. Any neurological disorder, except for Tourette's Syndrome.
                1. Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
                  Información Adicional *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Opciones de tratamiento

                    Brazos del estudio

                    INTERVENCIÓN ASIGNADA

                    Brazos del estudio

                    Experimental: KarXT

                    INTERVENCIÓN ASIGNADA
                    • Drug: KarXT

                    Brazos del estudio

                    Placebo Comparator: Placebo

                    INTERVENCIÓN ASIGNADA
                    • Other: KarXT Matching Placebo
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