# An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Clinical trial · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

- Archive id: nct:NCT05304767
- Published: 2022-03-31
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05304767
- Source URL: https://clinicaltrials.gov/study/NCT05304767
- Provenance: clinicaltrials

## 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 reproduced under 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._

## Trial details

- 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

Topics: [Novel Psychiatric Therapeutics](https://space-kitty.com/topics/psychiatric-therapeutics)

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