A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively
Eligibility
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk. Exclusion Criteria * Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have a…
Interventions
- DrugKarXT
Specified dose on specified days
Locations (55)
- Local Institution - 0077Anaheim, California
- Local Institution - 0058Chino, California
- Local Institution - 0083Redlands, California
- Local Institution - 0089San Francisco, California
- Local Institution - 0032Orlando, Florida
- Atlanta Center for Medical ResearchAtlanta, Georgia