An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Last updated: July 25, 2017
Sponsor: Alkermes, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Psychosis

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01895452
ALK9072-003EXT2
  • Ages 18-70
  • All Genders

Study Summary

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed the treatment period of Study ALK9072-003EXT

  • Continues to require chronic treatment with an antipsychotic medication

  • Continues to reside in a stable living situation

  • Continues to have an identified reliable informant

Exclusion

Exclusion Criteria:

  • Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) findingduring participation in Study ALK9072-003EXT that was clinically relevant and relatedto study drug

  • Missed more than 1 scheduled study visit during participation in the preceding StudyALK9072-003EXT

  • 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, or has pending legal action which may impactcompliance with study participation or procedures

Study Design

Total Participants: 291
Study Start date:
July 01, 2013
Estimated Completion Date:
June 30, 2016

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

    Varna,
    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 Lampur,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Kuching,
    Malaysia

    Site Not Available

  • Alkermes Investigational Site

    Ulu Kinta,
    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

    Quezon City,
    Philippines

    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

    Targu Mures,
    Romania

    Site Not Available

  • Alkermes Investigational Site

    Roshchino, Vyborgskiy
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Khotkovo,
    Russian Federation

    Site Not Available

  • Alkermes Investigational Site

    Leningrad,
    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

  • Roshchino township

    Samara,
    Russian Federation

    Site Not Available

  • Roshchino township

    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

    Chernigiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Donetsk,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kharkiv,
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Kherson,
    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

  • Roshchino township

    Vinnytsia, 61068
    Ukraine

    Site Not Available

  • Alkermes Investigational Site

    Little Rock, Arkansas 72201
    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
    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

    San Diego, California 92123
    United States

    Site Not Available

  • Alkermes Investigational Site

    Santa Ana, California
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, District of Columbia
    United States

    Site Not Available

  • Alkermes Investigational Site

    Washington, D.C., 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
    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 60611
    United States

    Site Not Available

  • Alkermes Investigational Site

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Alkermes Investigational Site

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Alkermes Investigational Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Alkermes Investigational Site

    Rockville, Maryland
    United States

    Site Not Available

  • Alkermes Investigational Site

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Alkermes Investigational Site

    St. Louis, Missouri
    United States

    Site Not Available

  • Alkermes Investigational Site

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Alkermes Investigational Site

    Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Alkermes Investigational Site

    Charleston, South Carolina
    United States

    Site Not Available

  • Alkermes Investigational Site

    Austin, Texas
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dallas, Texas 75243
    United States

    Site Not Available

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