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

NCT04987229 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-05-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

OLZ/SAM

Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • David McDonnell, MD · Alkermes, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987229 on ClinicalTrials.gov