Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Schizophrenia Clinical Trial

Official title:

Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04987229
• Other study ID #: ALKS 3831-A313
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 22, 2021
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 236
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

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.

Related Conditions & MeSH terms

• Bipolar I Disorder
• Schizophrenia

Intervention

Drug:
• OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Locations

Country	Name	City	State
Argentina	Alkermes Investigational Site	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Alkermes Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	Alkermes Investigational Site	Ciudad de Cordoba	Cordoba
Argentina	Alkermes Investigational Site	Ciudad de Mendoza	Mendoza
Argentina	Alkermes Investigational Site	Cordoba
Brazil	Alkermes Investigational Site	Curitiba	Parana
Brazil	Alkermes Investigational Site	Fortaleza	Ceará
Brazil	Alkermes Investigational Site	Goiania
Brazil	Alkermes Investigational Site	Rio de Janeiro
Brazil	Alkermes Investigational Site	Sao Paulo
Brazil	Alkermes Investigational Site	São Paulo
Colombia	Alkermes Investigational Site	Barranquilla
Colombia	Alkermes Investigational Site	Bello
Colombia	Alkermes Investigational Site	Bogotá
Colombia	Alkermes Investigational Site	Bogotá
Colombia	Alkermes Investigational Site	Pereira
Mexico	Alkermes Investigational Site	Culiacán	Sinaloa
Mexico	Alkermes Investigational Site	Gustavo A. Madero	Estado De Mexico
Mexico	Alkermes Investigational Site	León	Guanajuato
Mexico	Alkermes Investigational Site	Monterrey	Nuevo León
Mexico	Alkermes Investigational Site	Monterrey	Nuevo León
Mexico	Alkermes Investigational Site	San Luis Potosí	San Luis Potos
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	Colorado Springs	Colorado
United States	Alkermes Investigational Site	Decatur	Georgia
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Dothan	Alabama
United States	Alkermes Investigational Site	Encino	California
United States	Alkermes Investigational Site	Everett	Washington
United States	Alkermes Investigational Site	Fort Worth	Texas
United States	Alkermes Investigational Site	Hartford	Connecticut
United States	Alkermes Investigational Site	Indianapolis	Indiana
United States	Alkermes Investigational Site	Kansas City	Kansas
United States	Alkermes Investigational Site	Kinston	North Carolina
United States	Alkermes Investigational Site	Lincoln	Nebraska
United States	Alkermes Investigational Site	Miami	Florida
United States	Alkermes Investigational Site	Miami Lakes	Florida
United States	Alkermes Investigational Site	Saint Charles	Missouri
United States	Alkermes Investigational Site	Stanford	California
United States	Alkermes Investigational Site	Upland	California
United States	Alkermes Investigational Site	Washington	District of Columbia
United States	Alkermes Investigational Site	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 52 weeks