An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012 2. Subject has successfully completed the treatment period of Study KAR-012 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement) 4. Subject has been compliant with their background antipsychotic drug in Study KAR-012 in the opinion of the Investigator and based on subject and informant reporting Note: Subjects are required to remain on the same appropriate approved APD as in Study KAR-012 and should stay on that same dose throughout the study.…
Interventions
- DrugXanomeline and Trospium Chloride Capsules
KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID
Locations (175)
- Alea ResearchPhoenix, Arizona
- Pillar Clinical Research LLCLittle Rock, Arkansas
- Woodland International Research Group, LLCLittle Rock, Arkansas
- Advanced Research Center, Inc.Anaheim, California
- CITrials - BellflowerBellflower, California
- Local Institution - 110Cerritos, California