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An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)

ClinicalTrials.gov ID: NCT07744113

Public ClinicalTrials.gov record NCT07744113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 4:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To provide continued access to OLZ/SAM for pediatric participants with schizophrenia or bipolar I disorder who have completed participation in the ALKS 3831-A313 long-term safety extension study.

Study identification

NCT ID
NCT07744113
Recruitment status
Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Aug 3, 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Alkermes Investigator Site Miami Florida 33126 Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07744113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07744113 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →