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  • NCT07221877

Not Yet Recruiting

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

Oppdatert: 24 oktober, 2025   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 4

    Fase

  • Kjønn

  • 18-65

    Aldersgruppe

  • 16

    Sted(er)

  • Not Yet Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: KarXT
Drug: Xanomeline/trospium chloride

Nøkkelkriterier for kvalifikasjon

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

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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046