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

Last updated: April 2, 2025
Sponsor: Alkermes, Inc.
Overall Status: Active - Enrolling

Phase

3

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

OLZ/SAM

Clinical Study ID

NCT04987229
ALKS 3831-A313
  • Ages 10-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 subjecthad terminated early from Study ALKS 3831-A312 due to the clinically significantweight 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 hasfamily support available to be maintained as an outpatient.

  • Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator andhas agreed to provide support to the subject to ensure compliance with studytreatment, visits, and protocol procedures.

  • Subject agrees to abide by the contraception requirements specified in the protocolfor the duration of the study.

Exclusion

Exclusion Criteria:

  • Subject poses a current suicide risk as assessed by the Investigator or as confirmedby the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" toquestion 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 Monitorwould compromise the safety of the subject or affect their ability to fulfill theprotocol visit schedule or visit requirement.

  • Subject is currently taking medications that are contraindicated with olanzapine useor 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 andfor 90 days after any study drug administration.

Study Design

Total Participants: 236
Treatment Group(s): 1
Primary Treatment: OLZ/SAM
Phase: 3
Study Start date:
October 22, 2021
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Alkermes Investigational Site

    Ciudad Autonoma de Buenos Aire, Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Ciudad de Cordoba, Cordoba 5000
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Córdoba, Cordoba 5004
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Ciudad de Mendoza, Mendoza 5500
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Ciudad Autonoma Buenos Aires, C1405BOA
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Ciudad Autonoma de Buenos Aires, C1133AAH
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Cordoba, X5003DCE
    Argentina

    Site Not Available

  • Alkermes Investigational Site

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Alkermes Investigational Site

    Fortaleza, Ceará 60430-140
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    Curitiba, Parana 80240-280
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    Goiania, 74093-040
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    Rio de Janeiro, 22270-060
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    Sao Paulo, 01228-000
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    São Paulo, 05403-010
    Brazil

    Site Not Available

  • Alkermes Investigational Site

    Barranquilla, 110121
    Colombia

    Site Not Available

  • Alkermes Investigational Site

    Bello, 51053
    Colombia

    Site Not Available

  • Alkermes Investigational Site

    Bogotá, 111166
    Colombia

    Site Not Available

  • Alkermes Investigational Site

    Pereira, 660003
    Colombia

    Site Not Available

  • Alkermes Investigational Site

    Johor Bahru, Johor 80100
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Sungai Petani, Kedah 8000
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Seremban, Negeri Sembilan 70300
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Kuala Lumpur, Putrajaya 50603
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Gustavo A. Madero, Estado de Mexico C.P. 07000
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    León, Guanajuato 37000
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    Guadalajara, Jalisco 44100
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    Monterrey, Nuevo León 64710
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    San Luis Potosí, San Luis Potos 78213
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    Culiacán, Sinaloa 80230
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    Durango, 34200
    Mexico

    Site Not Available

  • Alkermes Investigational Site

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Alkermes Investigator Site

    Chandler, Arizona 84226
    United States

    Site Not Available

  • Alkermes Investigational Site

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Alkermes Investigational Site

    Anaheim, California 92805
    United States

    Site Not Available

  • Alkermes Investigational Site

    Encino, California 91316
    United States

    Site Not Available

  • Alkermes Investigational Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stanford, California 94305
    United States

    Site Not Available

  • Alkermes Investigational Site

    Upland, California 91786
    United States

    Site Not Available

  • Alkermes Investigational Site

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Alkermes Investigational Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Alkermes Investigational Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Alkermes Investigational Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Alkermes Investigational Site

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Alkermes Investigational Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Alkermes Investigational Site

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Alkermes Investigational Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Alkermes Investigational Site

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Alkermes Investigational Site

    Kinston, North Carolina 28501
    United States

    Site Not Available

  • Alkermes Investigational Site

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Alkermes Investigational Site

    West Chester, Ohio 45069
    United States

    Site Not Available

  • Alkermes Investigational Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Alkermes Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Alkermes Investigational Site

    Frisco, Texas 75034
    United States

    Site Not Available

  • Alkermes Investigational Site

    Richmond, Virginia 23220
    United States

    Site Not Available

  • Alkermes Investigational Site

    Everett, Washington 98201
    United States

    Site Not Available

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