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Szukaj Study Connect
  • NCT07221877

Recruiting

A Study to Evaluate the Effect of KarXT on Urological Safety - CN012-0068

Zaktualizowano: 2 czerwiec, 2026   |   ClinicalTrials.gov

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Szczegóły badania

  • Phase 4

    Etap

  • Płeć

  • 18-65

    Zakres wieku

  • 16

    Lokalizacje

  • Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: KarXT
Drug: Xanomeline/trospium chloride

Kluczowe kryteria kwalifikacyjne

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. - Other protocol-defined Inclusion/Exclusion criteria apply