An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age10-17
SponsorAlkermes, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- OLZ/SAM
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov