{"id":"nct:NCT05304767","kind":"trial","title":"An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia","authors":["Karuna Therapeutics, Inc., a Bristol Myers Squibb company"],"author_count":1,"year":2022,"published":"2022-03-31","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT05304767","source_url":"https://clinicaltrials.gov/study/NCT05304767","archive_url":"https://space-kitty.com/papers/nct:NCT05304767","updated":"2026-07-31","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \\[BID\\]) in subjects with schizophrenia.","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":290,"sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","conditions":["Schizophrenia"],"interventions":["DRUG: Xanomeline and Trospium Chloride Capsules"],"start_date":"2022-03-07","start_date_type":"ACTUAL","primary_completion_date":"2026-03-25","has_results":false,"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":[]}