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NCT07379827

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 55 → 68 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 16 entries
  2. Trial sites expanded: 52 → 55 locationsv6
  3. Trial sites expanded: 45 → 52 locationsv5
  4. Study sites: 46 to 45v4
  5. Trial sites expanded: 32 → 46 locationsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 32
    • Primary and study completion dates: Jun 30, 2028 to Jun 20, 2028
    • Start date changed from estimate of Feb 28, 2026 to Feb 26, 2026
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Treatment titration and switch regimens as described by the prescribing clinician
Timeframe: Baseline and up to 20 weeks

Secondary (16)

Adverse events (AEs)
Change in participant weight
Clinical Global Impressions - Improvement (CGI-I) score
Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms
Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study
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Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation
Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms
Date of first xanomeline and trospium chloride (KarXT) treatment
Participant age
Participant sex
Participant race
Participant ethnicity
Participant height
Participant's family history of schizophrenia
Duration since diagnosis of schizophrenia
Previous treatment(s) received for schizophrenia

Arms and interventions

Group 1

Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)

Drugs: Xanomeline and trospium chloride (KarXT)

Sites

68 sites in 1 country