NCT04987229
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Enrolling by Invitation
PHASE3Ages 10–17InterventionalTreatmentAlkermes, Inc.
~236 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:OLZ/SAM
At a glance
Recruiting sites
0 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 52 weeks
Conditions
Where it's being run
35 sites across 27 statesColombia5
Ohio2
Buenos Aires2
Brazil2
Nuevo León2
Alabama1
Arkansas1
California1
Study leadership
- David McDonnell, MD · STUDY_DIRECTOR · Alkermes, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Incidence of adverse eventsUp to 52 weeks