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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Schizophrenia; Bipolar I Disorder
• Intervention / Treatment: Drug: OLZ/SAM

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5003DCE
    • Alkermes Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1181ACH
      • Alkermes Investigational Site
    • La Plata, Buenos Aires, Argentina, 1900
      • Alkermes Investigational Site
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1133AAH
      • Alkermes Investigational Site
  • Mendoza Province
    • Mendoza, Mendoza Province, Argentina, 5500
      • Alkermes Investigational Site
• Brazil
  • Goiânia, Brazil, 74093-040
    • Alkermes Investigational Site
  • São Paulo, Brazil, 01228-000
    • Alkermes Investigational Site
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-140
      • Alkermes Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80240-280
      • Alkermes Investigational Site
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22270-060
      • Alkermes Investigational Site
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-010
      • Alkermes Investigational Site
• Colombia
  • Barranquilla, Colombia, 110121
    • Alkermes Investigational Site
  • Bello, Colombia, 51053
    • Alkermes Investigational Site
  • Bogotá, Colombia, 111166
    • Alkermes Investigational Site
  • Bogotá, Colombia, 80020
    • Alkermes Investigational Site
  • Pereira, Colombia, 660003
    • Alkermes Investigational Site
• Mexico
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Alkermes Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64620
      • Alkermes Investigational Site
    • Monterrey, Nuevo León, Mexico, 64710
      • Alkermes Investigational Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80230
      • Alkermes Investigational Site
  • State of Mexico
    • Gustavo A. Madero, State of Mexico, Mexico, C.P. 07000
      • Alkermes Investigational Site
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Alkermes Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Alkermes Investigational Site
  • California
    • Stanford, California, United States, 94305
      • Alkermes Investigational Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Alkermes Investigational Site
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Alkermes Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Alkermes Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Alkermes Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Alkermes Investigational Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Alkermes Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alkermes Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Alkermes Investigational Site
    • West Chester, Ohio, United States, 45069
      • Alkermes Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Alkermes Investigational Site
  • Washington
    • Everett, Washington, United States, 98201
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)	Drug: OLZ/SAM; Olanzapine and Samidorphan fixed dose coated tablet taken once daily; Other Names: ALKS 3831

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: David McDonnell, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Schizophrenia; Pediatric; Bipolar I Disorder; Samidorphan; LYBALVI; Olzanzapine
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: ALKS 3831-A313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No