Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (NCT04987229) | Clinical Trial Compass
By InvitationPhase 3
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
United States, Argentina, Brazil236 participantsStarted 2021-10-22
Plain-language summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion.
* Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
* Subject is able to be treated on an outpatient basis.
* Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
* Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
* Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study.
Exclusion Criteria:
* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit.
* Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement.
* Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction po…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a long-term safety extension study for a pediatric population, what does that mean for my child — are they mainly watching for side effects over time rather than testing whether the drug works?
2My child has been diagnosed with bipolar I disorder or schizophrenia — does this trial require them to have already been in an earlier OLZ/SAM study, and if so, does my child even qualify to be considered?
3Because the trial is 'enrolling by invitation only,' what would need to happen for my child's care team to put them forward, and what should I do if I want to explore that possibility?
4OLZ/SAM combines olanzapine with samidorphan — can you explain what we already know about the safety profile of this combination in kids, and what kinds of adverse events the study is specifically designed to watch for?
5Given that this is a long-term extension study, what would my child's standard treatment options look like if we don't pursue this trial, and how do those options compare in terms of what's known about safety and effectiveness?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.