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L'essai clinique NCT07379827 pour Schizophrénie est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) 1 500 Données vie réelle

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07379827 est une étude observationnel pour Schizophrénie. Son statut actuel est : en recrutement. L'étude a débuté le 26 février 2026 et vise à recruter 1 500 participants. Dirigée par Bristol-Myers Squibb, l'étude devrait être terminée d'ici le 20 juin 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 6 mars 2026.
Résumé succinct
The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States
Titre officiel

Effectiveness and Adverse-effect Switch Evaluation

Pathologies
Schizophrénie
Autres identifiants de l'étude
  • CN012-0134
Numéro NCT
Date de début (réel)
2026-02-26
Dernière mise à jour publiée
2026-03-06
Date de fin (estimée)
2028-06-20
Inscription (estimée)
1 500
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
Schizophrenia
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Group 1
Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)
Xanomeline and trospium chloride (KarXT)
According to the product label
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Treatment titration and switch regimens as described by the prescribing clinician
Baseline and up to 20 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Adverse events (AEs)
Baseline and up to 20 weeks
Change in participant weight
Baseline and up to 20 weeks
Clinical Global Impressions - Improvement (CGI-I) score
Baseline and up to 20 weeks
Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms
Baseline and up to 20 weeks
Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study
Baseline and up to 20 weeks
Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation
Baseline and up to 20 weeks
Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms
Baseline and up to 20 weeks
Date of first xanomeline and trospium chloride (KarXT) treatment
Baseline
Participant age
Baseline
Participant sex
Baseline
Participant race
Baseline
Participant ethnicity
Baseline
Participant height
Baseline
Participant's family history of schizophrenia
Baseline
Duration since diagnosis of schizophrenia
Baseline
Previous treatment(s) received for schizophrenia
Baseline
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.

  • Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.

  • Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:

    • Be within <16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR
    • On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.
  • Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.

  • Prior use of KarXT that has been discontinued for any reason prior to Baseline.
  • Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.
  • Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.
  • In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are < 16 weeks from initiation of KarXT.
  • Participants who are pregnant, planning to become pregnant, or breastfeeding.
Bristol-Myers Squibb logoBristol-Myers Squibb
Contact central de l'étude
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
32 Centres de l'étude dans 1 pays

Arkansas

Local Institution - 0009, Bryant, Arkansas, 72022, United States
Site 0009, Contact
Pas encore en recrutement

California

Local Institution - 0003, Anaheim, California, 92805, United States
Site 0003, Contact
Pas encore en recrutement
Local Institution - 0012, La Palma, California, 90623, United States
Site 0012, Contact
Pas encore en recrutement
Local Institution - 0028, Stanford, California, 94303, United States
Site 0028, Contact
Pas encore en recrutement

Florida

Local Institution - 0005, Bonita Springs, Florida, 34134, United States
Site 0005, Contact
Pas encore en recrutement
Local Institution - 0019, Hialeah, Florida, 33016-1814, United States
Site 0019, Contact
Pas encore en recrutement
Local Institution - 0030, Homestead, Florida, 33030, United States
Site 0030, Contact
Pas encore en recrutement
Local Institution - 0029, Kendall, Florida, 33186, United States
Site 0029, Contact
Pas encore en recrutement
Local Institution - 0032, Miami, Florida, 33015, United States
Site 0032, Contact
Pas encore en recrutement
Local Institution - 0011, Miami, Florida, 33134, United States
Site 0011, Contact
Pas encore en recrutement
Local Institution - 0007, Miami, Florida, 33155, United States
Site 0007, Contact
Pas encore en recrutement
Local Institution - 0006, Miami, Florida, 33175, United States
Site 0006, Contact
Pas encore en recrutement
Local Institution - 0023, Orange City, Florida, 32763, United States
Site 0023, Contact
Pas encore en recrutement

Georgia

Local Institution - 0025, Atlanta, Georgia, 30303, United States
Site 0025, Contact
Pas encore en recrutement

Michigan

Local Institution - 0014, Bloomfield Township, Michigan, 48302-1909, United States
Site 0014, Contact
Pas encore en recrutement

New York

Local Institution - 0004, Monsey, New York, 10952, United States
Site 0004, Contact
Pas encore en recrutement
Local Institution - 0020, White Plains, New York, 10601, United States
Site 0020, Contact
Pas encore en recrutement

North Carolina

PPD Virtual - PPD - US, Wilmington, North Carolina, 28401, United States
Pas encore en recrutement

Ohio

Local Institution - 0031, Mason, Ohio, 45040-7846, United States
Site 0031, Contact
Pas encore en recrutement

Oklahoma

Local Institution - 0027, Oklahoma City, Oklahoma, 73112-8729, United States
Site 0027, Contact
Pas encore en recrutement

Pennsylvania

Local Institution - 0015, Philadelphia, Pennsylvania, 19104-4238, United States
Site 0015, Contact
Pas encore en recrutement

Tennessee

Psychiatric Consultants, Pc, Franklin, Tennessee, 37607, United States
James Hart, Site 0002, Contact, 615-807-4025
En recrutement

Texas

Local Institution - 0016, Austin, Texas, 78754, United States
Site 0016, Contact
Pas encore en recrutement
Local Institution - 0021, Fort Worth, Texas, 76132, United States
Site 0021, Contact
Pas encore en recrutement
Local Institution - 0026, Houston, Texas, 77008, United States
Site 0026, Contact
Pas encore en recrutement
Local Institution - 0022, Houston, Texas, 77054-2852, United States
Site 0022, Contact
Pas encore en recrutement
Local Institution - 0010, Houston, Texas, 77054, United States
Site 0010, Contact
Pas encore en recrutement
Local Institution - 0024, Houston, Texas, 77099, United States
Site 0024, Contact
Pas encore en recrutement
Local Institution - 0017, Irving, Texas, 75062-2757, United States
Site 0017, Contact
Pas encore en recrutement
Local Institution - 0013, McKinney, Texas, 75092, United States
Site 0013, Contact
Pas encore en recrutement
Local Institution - 0008, Richmond, Texas, 77407-3498, United States
Site 0008, Contact
Pas encore en recrutement
Local Institution - 0018, Stafford, Texas, 77477-3954, United States
Site 0018, Contact
Pas encore en recrutement