Clinical Trial

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

Enrolling by Invitation Phase 3
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Summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2021-07-26; most recent amendment 2026-06-01.
Status change: Not Yet Recruiting → Enrolling by Invitation 2021-10-21
Trial Details
NCT Number NCT04987229
Lead Sponsor Alkermes, Inc.
Conditions Bipolar I Disorder, Schizophrenia
Enrollment 236 participants
Start Date 2021-10-22
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-14