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
Status: Recruiting
Location: See all (59) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• \- 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.
Locations
United States
California
Local Institution - 0077
NOT_YET_RECRUITING
Anaheim
Local Institution - 0058
NOT_YET_RECRUITING
Chino
Local Institution - 0024
NOT_YET_RECRUITING
Culver City
Local Institution - 0083
NOT_YET_RECRUITING
Redlands
Local Institution - 0089
NOT_YET_RECRUITING
San Francisco
Florida
Apg Research, Llc
RECRUITING
Orlando
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Salveo Integrative Health - Lawrenceville
RECRUITING
Lawrenceville
Local Institution - 0039
NOT_YET_RECRUITING
Stone Mountain
Illinois
EmVenio Research Center - Prime Healthcare
RECRUITING
Chicago
Massachusetts
Local Institution - 0076
NOT_YET_RECRUITING
Boston
Local Institution - 0059
NOT_YET_RECRUITING
Worcester
New York
Local Institution - 0061
NOT_YET_RECRUITING
Great Neck
Ohio
University of Cincinnati Cancer Institute
RECRUITING
Cincinnati
Pennsylvania
Local Institution - 0097
NOT_YET_RECRUITING
Philadelphia
Tennessee
Local Institution - 0137
NOT_YET_RECRUITING
Nashville
Texas
Local Institution - 0046
NOT_YET_RECRUITING
Garland
Local Institution - 0066
NOT_YET_RECRUITING
Spring
Virginia
Local Institution - 0050
NOT_YET_RECRUITING
Richmond
Other Locations
Argentina
Local Institution - 0036
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0084
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0035
NOT_YET_RECRUITING
Córdoba
Local Institution - 0085
NOT_YET_RECRUITING
La Plata
Local Institution - 0116
NOT_YET_RECRUITING
Santiago Del Estero
Canada
Local Institution - 0111
NOT_YET_RECRUITING
Edmonton
Local Institution - 0110
NOT_YET_RECRUITING
Kingston
Local Institution - 0112
NOT_YET_RECRUITING
Montreal
Local Institution - 0113
NOT_YET_RECRUITING
Toronto
France
Local Institution - 0118
NOT_YET_RECRUITING
Bordeaux
Local Institution - 0120
NOT_YET_RECRUITING
Bron
Local Institution - 0119
NOT_YET_RECRUITING
Paris
Germany
Local Institution - 0121
NOT_YET_RECRUITING
Gdansk
Hungary
Local Institution - 0129
NOT_YET_RECRUITING
Budapest
Local Institution - 0130
NOT_YET_RECRUITING
Gyula
Local Institution - 0131
NOT_YET_RECRUITING
Szeged
Japan
Local Institution - 0086
NOT_YET_RECRUITING
Bunkyo-ku
Local Institution - 0075
NOT_YET_RECRUITING
Chikugo
Local Institution - 0062
NOT_YET_RECRUITING
Miyakonojō
Local Institution - 0056
NOT_YET_RECRUITING
Ōta-ku
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING
Sapporo
Local Institution - 0063
NOT_YET_RECRUITING
Yokohama, Kanagawa
Local Institution - 0025
NOT_YET_RECRUITING
Zentsujichó
Poland
Local Institution - 0126
NOT_YET_RECRUITING
Gdansk
Local Institution - 0124
NOT_YET_RECRUITING
Katowice
Local Institution - 0122
NOT_YET_RECRUITING
Kraśnik
Local Institution - 0128
NOT_YET_RECRUITING
Poznan
Local Institution - 0123
NOT_YET_RECRUITING
Szczecin
Local Institution - 0127
NOT_YET_RECRUITING
Warsaw
Local Institution - 0125
NOT_YET_RECRUITING
Wroclaw
Romania
Local Institution - 0029
NOT_YET_RECRUITING
Bucharest
Local Institution - 0040
NOT_YET_RECRUITING
Bucharest
Local Institution - 0042
NOT_YET_RECRUITING
Bucharest
Local Institution - 0031
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0008
NOT_YET_RECRUITING
Iași
Local Institution - 0038
NOT_YET_RECRUITING
Timișoara
Spain
Local Institution - 0099
NOT_YET_RECRUITING
Barcelona
Local Institution - 0101
NOT_YET_RECRUITING
Barcelona
Local Institution - 0098
NOT_YET_RECRUITING
Madrid
Local Institution - 0100
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2030-03-08
Participants
Target number of participants: 400
Treatments
Experimental: Administration of KarXT for Schizophrenia
Experimental: Administration of KarXT for Autism-related Irritability
Related Therapeutic Areas
Sponsors
Leads: Karuna Therapeutics, Inc., a Bristol Myers Squibb company