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Clinical Trials in the USA / NCT04987229
Enrolling by invitation Phase 3

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

NCT04987229 · tracked via the Priya Life Science USA tracker
Sponsor
Alkermes, Inc.
Phase
Phase 3
Started
2021-10-22
Last updated
2026-08-14

Condition(s) studied

Bipolar I DisorderSchizophrenia

Investigational drug(s) / intervention(s)

OLZ/SAM →

OLZ/SAM: Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Study summary

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion. * Subject will benefit from continued therapy with OLZ/SAM per clinical judgment. * Subject is able to be treated on an outpatient basis. * Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. * Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. * Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study. Exclusion Criteria: * Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit. * Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement. * Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine * Subject has a positive test for opioids. * Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
Alkermes Investigational Site Dothan Alabama
Alkermes Investigational Site Little Rock Arkansas
Alkermes Investigational Site Stanford California
Alkermes Investigational Site Washington D.C. District of Columbia
Alkermes Investigational Site Miami Lakes Florida
Alkermes Investigational Site Decatur Georgia
Alkermes Investigational Site Chicago Illinois
Alkermes Investigational Site Indianapolis Indiana
Alkermes Investigational Site Saint Charles Missouri
Alkermes Investigational Site Lincoln Nebraska
Alkermes Investigator Site New York New York
Alkermes Investigational Site Cincinnati Ohio
Alkermes Investigational Site West Chester Ohio
Alkermes Investigational Site Richmond Virginia
Alkermes Investigational Site Everett Washington
Alkermes Investigational Site Ciudad Autonoma de Buenos Aire Buenos Aires
Alkermes Investigational Site La Plata Buenos Aires
Alkermes Investigational Site Buenos Aires Buenos Aires F.D.
Alkermes Investigational Site Mendoza Mendoza Province
Alkermes Investigational Site Córdoba Argentina
Alkermes Investigational Site Fortaleza Ceará
Alkermes Investigational Site Curitiba Paraná
Alkermes Investigational Site Rio de Janeiro Rio de Janeiro
Alkermes Investigational Site São Paulo São Paulo
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 Pereira Colombia
Alkermes Investigational Site León Guanajuato
Alkermes Investigational Site Monterrey Nuevo León
Alkermes Investigational Site Monterrey Nuevo León
Alkermes Investigational Site Culiacán Sinaloa
Alkermes Investigational Site Gustavo A. Madero State of Mexico

More Alkermes, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04987229 on ClinicalTrials.gov ↗ ← All trials in the USA