Clinical trial NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Official title: Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Bipolar I Disorder
Schizophrenia
Keywords: Bipolar I Disorder
Schizophrenia
Samidorphan
Pediatric
Olzanzapine
Safety
LYBALVI
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 236
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder


Eligibility criteria: 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 outcomes:
measure: Incidence of adverse events
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Stanford
country: United States
facility: Alkermes Investigational Site
state: California
city: Upland
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Miami Lakes
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Saint Charles
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Alkermes Investigational Site
state: Nebraska
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: West Chester
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Richmond
country: United States
facility: Alkermes Investigational Site
state: Virginia
city: Everett
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Alkermes Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Alkermes Investigational Site
state: Buenos Aires
city: Ciudad de Mendoza
country: Argentina
facility: Alkermes Investigational Site
state: Mendoza
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Alkermes Investigational Site
city: Cordoba
country: Argentina
facility: Alkermes Investigational Site
city: Fortaleza
country: Brazil
facility: Alkermes Investigational Site
state: Ceará
city: Curitiba
country: Brazil
facility: Alkermes Investigational Site
state: Parana
city: Goiania
country: Brazil
facility: Alkermes Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Alkermes Investigational Site
city: Sao Paulo
country: Brazil
facility: Alkermes Investigational Site
city: São Paulo
country: Brazil
facility: Alkermes Investigational Site
city: Barranquilla
country: Colombia
facility: Alkermes Investigational Site
city: Bello
country: Colombia
facility: Alkermes Investigational Site
city: Bogotá
country: Colombia
facility: Alkermes Investigational Site
city: Bogotá
country: Colombia
facility: Alkermes Investigational Site
city: Pereira
country: Colombia
facility: Alkermes Investigational Site
city: Gustavo A. Madero
country: Mexico
facility: Alkermes Investigational Site
state: Estado de Mexico
city: León
country: Mexico
facility: Alkermes Investigational Site
state: Guanajuato
city: Monterrey
country: Mexico
facility: Alkermes Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: Alkermes Investigational Site
state: Nuevo León
city: San Luis Potosí
country: Mexico
facility: Alkermes Investigational Site
state: San Luis Potos
city: Culiacán
country: Mexico
facility: Alkermes Investigational Site
state: Sinaloa
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References: