Clinical Trials in Mexico / NCT04987229
Enrolling by invitation
Phase 3
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
NCT04987229 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Bipolar I DisorderSchizophrenia
Investigational drug(s) / intervention(s)
OLZ/SAM: Olanzapine and Samidorphan fixed dose coated tablet taken once daily
Study summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Eligibility
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 potential with olanzapine
* Subject has a positive test for opioids.
* Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.
Primary outcome measure(s)
- Incidence of adverse events — Up to 52 weeks
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Alkermes Investigational Site | Dothan | Alabama | |
| Alkermes Investigational Site | Little Rock | Arkansas | |
| Alkermes Investigational Site | Stanford | California | |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | |
| Alkermes Investigational Site | Miami Lakes | Florida | |
| Alkermes Investigational Site | Decatur | Georgia | |
| Alkermes Investigational Site | Chicago | Illinois | |
| Alkermes Investigational Site | Indianapolis | Indiana | |
| Alkermes Investigational Site | Saint Charles | Missouri | |
| Alkermes Investigational Site | Lincoln | Nebraska | |
| Alkermes Investigator Site | New York | New York | |
| Alkermes Investigational Site | Cincinnati | Ohio | |
| Alkermes Investigational Site | West Chester | Ohio | |
| Alkermes Investigational Site | Richmond | Virginia | |
| Alkermes Investigational Site | Everett | Washington | |
| Alkermes Investigational Site | Ciudad Autonoma de Buenos Aire | Buenos Aires | |
| Alkermes Investigational Site | La Plata | Buenos Aires | |
| Alkermes Investigational Site | Buenos Aires | Buenos Aires F.D. | |
| Alkermes Investigational Site | Mendoza | Mendoza Province | |
| Alkermes Investigational Site | Córdoba | Argentina | |
| Alkermes Investigational Site | Fortaleza | Ceará | |
| Alkermes Investigational Site | Curitiba | Paraná | |
| Alkermes Investigational Site | Rio de Janeiro | Rio de Janeiro | |
| Alkermes Investigational Site | São Paulo | São Paulo | |
| Alkermes Investigational Site | Goiânia | Brazil | |
| Alkermes Investigational Site | São Paulo | Brazil | |
| Alkermes Investigational Site | Barranquilla | Colombia | |
| Alkermes Investigational Site | Bello | Colombia | |
| Alkermes Investigational Site | Bogotá | Colombia | |
| Alkermes Investigational Site | Pereira | Colombia | |
| Alkermes Investigational Site | León | Guanajuato | |
| Alkermes Investigational Site | Monterrey | Nuevo León | |
| Alkermes Investigational Site | Monterrey | Nuevo León | |
| Alkermes Investigational Site | Culiacán | Sinaloa | |
| Alkermes Investigational Site | Gustavo A. Madero | State of Mexico |
More Alkermes, Inc. trials in Mexico
Other trials for the same condition
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04987229 on ClinicalTrials.gov ↗ ← All trials in Mexico