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Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Sponsor: Alkermes, Inc.
Summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Official title: Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2021-10-22
Completion Date
2027-09
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily
Locations (36)
Alkermes Investigational Site
Dothan, Alabama, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Stanford, California, United States
Alkermes Investigator Site
Denver, Colorado, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Miami Lakes, Florida, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Indianapolis, Indiana, United States
Alkermes Investigational Site
Saint Charles, Missouri, United States
Alkermes Investigational Site
Lincoln, Nebraska, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
West Chester, Ohio, United States
Alkermes Investigational Site
Richmond, Virginia, United States
Alkermes Investigational Site
Everett, Washington, United States
Alkermes Investigational Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Alkermes Investigational Site
La Plata, Buenos Aires, Argentina
Alkermes Investigational Site
Buenos Aires, Buenos Aires F.D., Argentina
Alkermes Investigational Site
Mendoza, Mendoza Province, Argentina
Alkermes Investigational Site
Córdoba, Argentina
Alkermes Investigational Site
Fortaleza, Ceará, Brazil
Alkermes Investigational Site
Curitiba, Paraná, Brazil
Alkermes Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Alkermes Investigational Site
São Paulo, São Paulo, Brazil
Alkermes Investigational Site
Goiânia, Brazil
Alkermes Investigational Site
São Paulo, Brazil
Alkermes Investigational Site
Barranquilla, Colombia
Alkermes Investigational Site
Bello, Colombia
Alkermes Investigational Site
Bogotá, Colombia
Alkermes Investigational Site
Bogotá, Colombia
Alkermes Investigational Site
Pereira, Colombia
Alkermes Investigational Site
León, Guanajuato, Mexico
Alkermes Investigational Site
Monterrey, Nuevo León, Mexico
Alkermes Investigational Site
Monterrey, Nuevo León, Mexico
Alkermes Investigational Site
Culiacán, Sinaloa, Mexico
Alkermes Investigational Site
Gustavo A. Madero, State of Mexico, Mexico