NCT04987229

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P50-P75 for phase_3

Timeline
16mo left

Started Oct 2021

Longer than P75 for phase_3

Geographic Reach
5 countries

36 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Oct 2021Sep 2027

First Submitted

Initial submission to the registry

July 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

5.9 years

First QC Date

July 26, 2021

Last Update Submit

May 5, 2026

Conditions

Bipolar I DisorderSchizophrenia

Keywords

Bipolar I DisorderSchizophreniaSamidorphanPediatricOlzanzapineSafetyLYBALVI

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Up to 52 weeks

Study Arms (1)

All subjects

EXPERIMENTAL

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

Interventions

OLZ/SAMDRUG

Olanzapine and Samidorphan fixed dose coated tablet taken once daily

Also known as: ALKS 3831
All subjects

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Alkermes Investigational Site

Dothan, Alabama, 36303, United States

Location

Alkermes Investigational Site

Little Rock, Arkansas, 72204, United States

Location

Alkermes Investigational Site

Stanford, California, 94305, United States

Location

Alkermes Investigator Site

Denver, Colorado, 80202, United States

Location

Alkermes Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

Alkermes Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60611, United States

Location

Alkermes Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Alkermes Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Alkermes Investigational Site

Lincoln, Nebraska, 68526, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Alkermes Investigational Site

West Chester, Ohio, 45069, United States

Location

Alkermes Investigational Site

Richmond, Virginia, 23220, United States

Location

Alkermes Investigational Site

Everett, Washington, 98201, United States

Location

Alkermes Investigational Site

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1181ACH, Argentina

Location

Alkermes Investigational Site

La Plata, Buenos Aires, 1900, Argentina

Location

Alkermes Investigational Site

Buenos Aires, Buenos Aires F.D., C1133AAH, Argentina

Location

Alkermes Investigational Site

Mendoza, Mendoza Province, 5500, Argentina

Location

Alkermes Investigational Site

Córdoba, X5003DCE, Argentina

Location

Alkermes Investigational Site

Fortaleza, Ceará, 60430-140, Brazil

Location

Alkermes Investigational Site

Curitiba, Paraná, 80240-280, Brazil

Location

Alkermes Investigational Site

Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil

Location

Alkermes Investigational Site

São Paulo, São Paulo, 05403-010, Brazil

Location

Alkermes Investigational Site

Goiânia, 74093-040, Brazil

Location

Alkermes Investigational Site

São Paulo, 01228-000, Brazil

Location

Alkermes Investigational Site

Barranquilla, 110121, Colombia

Location

Alkermes Investigational Site

Bello, 51053, Colombia

Location

Alkermes Investigational Site

Bogotá, 111166, Colombia

Location

Alkermes Investigational Site

Bogotá, 80020, Colombia

Location

Alkermes Investigational Site

Pereira, 660003, Colombia

Location

Alkermes Investigational Site

León, Guanajuato, 37000, Mexico

Location

Alkermes Investigational Site

Monterrey, Nuevo León, 64620, Mexico

Location

Alkermes Investigational Site

Monterrey, Nuevo León, 64710, Mexico

Location

Alkermes Investigational Site

Culiacán, Sinaloa, 80230, Mexico

Location

Alkermes Investigational Site

Gustavo A. Madero, State of Mexico, C.P. 07000, Mexico

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • David McDonnell, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 3, 2021

Study Start

October 22, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

US(15)AR(5)BR(6)CO(5)ME(5)