{"id":"nct:NCT04820309","kind":"trial","title":"An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)","authors":["Karuna Therapeutics, Inc., a Bristol Myers Squibb company"],"author_count":1,"year":2021,"published":"2021-03-29","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT04820309","source_url":"https://clinicaltrials.gov/study/NCT04820309","archive_url":"https://space-kitty.com/papers/nct:NCT04820309","updated":"2025-09-17","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is a Phase 3, multicenter, 56-week, outpatient, open-label (OL) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in de novo subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia. In this OL study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \\[BID\\]) for up to 52 weeks. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and characterize the pharmacokinetics of xanomeline and trospium after administration of KarXT.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Schizophrenia"],"details":{"acronym":null,"status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":566,"sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","conditions":["Schizophrenia"],"interventions":["DRUG: Xanomeline and Trospium Chloride Capsules"],"start_date":"2021-06-02","start_date_type":"ACTUAL","primary_completion_date":"2024-05-24","has_results":true,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"psychiatric-therapeutics","name":"Novel Psychiatric Therapeutics","domain_slug":"neuroscience"}],"cited_in_dossiers":[{"slug":"psychiatric-therapeutics","title":"Novel Psychiatric Therapeutics: State of the Field (October 2026)","url":"https://space-kitty.com/dossiers/psychiatric-therapeutics"}]}