An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)
Purpose
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.
Conditions
- Bipolar 1 Disorder
- Schizophrenia Disorder
Eligibility
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- The Participant has completed 52-weeks on the ALKS 3831-A313 clinical study. - The Participant must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. - The Participant will benefit from continued therapy with OLZ/SAM per the clinical judgment of the Participant's Physician. - The Participant can be treated on an outpatient basis. - The Participant agrees to abide by the contraception requirements specified in the protocol for the duration of the study. - The Participant's parent(s)/legal guardian(s) is/are considered reliable by the Physician and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
Exclusion Criteria
- The participant is eligible for commercial OLZ/SAM (LYBALVI®) through standard commercial pathways (≥18) for approved use. - The participant is at a current risk of suicidal behavior as assessed by the Participant's Physician or answered "Yes" to questions 4 or 5 on the C-SSRS and/or had a suicide attempt within the past 12 months. - The participant has any finding that in the view of the Physician would compromise the safety of the Participant or affect their ability to fulfill the Program requirements. - The participant is currently taking medications that are contraindicated with olanzapine or OLZ/SAM use or exhibit drug interaction potential with olanzapine or OLZ/SAM (such as the Participant is currently using opioids or undergoing acute opioid withdrawal). - The participant has a positive test for opioids. - The participant is currently enrolled in an interventional clinical study or Early (or Expanded) Access Program (other than the OLZ/SAM Program) or used any investigational drug or device (other than the OLZ/SAM) within 30 days prior to starting the Program. - The participant has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the Program and for 90 days after any treatment with OLZ/SAM.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
More Details
- Status
- Available
- Sponsor
- Alkermes, Inc.
Study Contact
Senior Director Global Clinical Services888-235-8008 (US Only)
clinicaltrials@alkermes.com
