A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Last updated: August 28, 2018
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Psychosis

Treatment

N/A

Clinical Study ID

NCT01626456
ALK9072-003EXT
  • Ages 18-70
  • All Genders

Study Summary

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Completed the ALK9072-003 Day 85 visit

  • Continues to require treatment with an antipsychotic medication

(New Subjects)

  • On a stable dose of oral antipsychotic medication

  • Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual ofMental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable

  • Has been able to achieve outpatient status for more than 3 months prior to screening

  • Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

  • Resides in a stable living situation

Exclusion

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding duringparticipation in study ALK9072-003 that was clinically relevant and related to studydrug

  • Missed more than 1 scheduled study visit during participation in study ALK9072-003

  • Has a significant or unstable medical condition that would preclude safe completion ofthe current study

  • Subject is pregnant or breastfeeding

  • Subject expects to be incarcerated in the next 12 months, or has pending legal actionwhich may impact compliance with study participation or procedures

(New Subjects)

  • History of poor or inadequate clinical response to treatment with aripiprazole

  • History of treatment resistance

  • Diagnosis of current substance dependence (including alcohol)

  • Pregnant, lactating, or breastfeeding

  • Has received any long-acting intramuscular antipsychotic medication within 60 daysprior to screening

  • Currently under involuntary hospitalization

  • Current or expected incarceration Additional inclusion/exclusion criteria may apply

Study Design

Total Participants: 478
Study Start date:
June 01, 2012
Estimated Completion Date:
April 30, 2015

Connect with a study center

  • Alkermes Investigational Site

    Burgas,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Kazanlak,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Novi Iskar,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Pazardzhik,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Pleven,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Plovdiv,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Radnevo,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Ruse,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Stara Zagora,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Targovishte,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Veliko Tarnovo,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Vratsa,
    Bulgaria

    Site Not Available

  • Alkermes Investigational Site

    Jeju-si,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Jeollanam-do,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Alkermes Investigational Site

    Cheras,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Johor Bahru,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Kuching,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Mariveles, Bataan
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Cebu City,
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Iloilo City,
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Mandaluyong City,
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Manila,
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Pasig City,
    Philippines

    Site Not Available

  • Alkermes Investigational Site

    Targu Mures, Mures
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Craiova,
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Iasi,
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Oradea,
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Nikol'skoye, Gatchinckiy
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Staritsa, Orenburg
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Khotkovo,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Lipetsk,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Nizhniy Novgorod,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Samara,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Saratov,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Stavropol,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Talagi,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Voronezh,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Yaroslavl,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Stepanovka, Kherson
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Chernigiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Donetsk,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kharkiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kyiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Lugansk,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Lviv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Poltava,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Simferopol,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Ternopil,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Uzhgorod,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Vinnytsia,
    Ukraine

    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

    Garden Grove, California 92845
    United States

    Site Not Available

  • Alkermes Investigational Site

    La Habra, California 90631
    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

    San Diego, California 92123
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Alkermes Investigational Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Alkermes Investigational Site

    Ft. Lauderdale, Florida 33308
    United States

    Site Not Available

  • Alkermes Investigational Site

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Alkermes Investigational Site

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Alkermes Investigational Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Alkermes Investigational Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Alkermes Investigational Site

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Alkermes Investigational Site

    Saint Louis, Missouri 63118
    United States

    Site Not Available

  • Alkermes Investigational Site

    St. Louis, Missouri 63118
    United States

    Site Not Available

  • Alkermes Investigational Site

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • Alkermes Investigational Site

    Charleston, South Carolina 29407
    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

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