drugset / Trial / NCT04987229

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

NCT04987229

Phase 3 Enrolling by invitation 236 enrolled Alkermes, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2021-10-22
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule
Subject Samidorphan Small molecule