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Rechercher Study Connect

Not Yet Recruiting

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

Mis à jour: 24 octobre, 2025   |   ClinicalTrials.gov

Résumé imprimable

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Détails de l’essai

  • Phase 4

    Phase

  • Sexe(s)

  • 18-65

    Tranche d’âge

  • 16

    Site(s)

  • Not Yet Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: KarXT
Drug: Xanomeline/trospium chloride

Principaux critères d’éligibilité

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

Nous vous recommandons vivement de contacter BMS pour signaler les effets secondaires (événements indésirables)
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
Signaler des plaintes concernant des effets indésirables (effets indésirables) ou des produits: Informations médicales