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ENROLLING BY INVITATION
NCT04987229
PHASE3

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Sponsor: Alkermes, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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