A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Last updated: July 20, 2021
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

N/A

Clinical Study ID

NCT02873208
ALK3831-A304
  • Ages 18-55
  • All Genders

Study Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Agrees to use an acceptable method of contraception for the duration of the study
  • Subject has completed the 24-week treatment period in the antecedent study,ALK3831-A303, within 7 days
  • Additional criteria may apply

Exclusion

Exclusion Criteria:

  • Subject is currently taking medications that are contraindicated with olanzapine useor exhibit drug-interaction potential with olanzapine
  • Subject has a positive test for drugs of abuse at study entry
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study
  • Additional criteria may apply

Study Design

Total Participants: 266
Study Start date:
August 07, 2016
Estimated Completion Date:
October 17, 2019

Connect with a study center

  • Alkermes Investigational Site

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • Alkermes Investigational Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Alkermes Investigational Site

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Alkermes Investigational Site

    Anaheim, California 92805
    United States

    Site Not Available

  • Alkermes Investigational Site

    Cerritos, California 90703
    United States

    Site Not Available

  • Alkermes Investigational Site

    Culver City, California 90230
    United States

    Site Not Available

  • Alkermes Investigational Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Alkermes Investigational Site

    Glendale, California 91206
    United States

    Site Not Available

  • Alkermes Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Alkermes Investigational Site

    Long Beach, California 90822
    United States

    Site Not Available

  • Alkermes Investigational Site

    National City, California 91950
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oakland, California 94612
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Alkermes Investigational Site

    Orange, California 92868
    United States

    Site Not Available

  • Alkermes Investigational Site

    Pico Rivera, California 90660
    United States

    Site Not Available

  • Alkermes Investigational Site

    Redlands, California 92374
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Diego, California 92103
    United States

    Site Not Available

  • Alkermes Investigational Site

    Temecula, California 92591
    United States

    Site Not Available

  • Alkermes Investigational Site

    Torrance, California 90502
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Alkermes Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Alkermes Investigational Site

    North Miami, Florida 33161
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oakland Park, Florida 33334
    United States

    Site Not Available

  • Alkermes Investigational Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Alkermes Investigational Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Alkermes Investigational Site

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Alkermes Investigational Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Alkermes Investigational Site

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Alkermes Investigational Site

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Alkermes Investigational Site

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Alkermes Investigational Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Alkermes Investigational Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Alkermes Investigational Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Alkermes Investigational Site

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Alkermes Investigational Site

    Jamaica, New York 11432
    United States

    Site Not Available

  • Alkermes Investigational Site

    Rochester, New York 14615
    United States

    Site Not Available

  • Alkermes Investigational Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Alkermes Investigational Site

    Austin, Texas 78754
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dallas, Texas 75243
    United States

    Site Not Available

  • Alkermes Investigational Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Alkermes Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Alkermes Investigational Site

    Bellevue, Washington 98007
    United States

    Site Not Available

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