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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:7/15/2016
Start Date:July 2013
End Date:June 2016

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A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

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.


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 Criteria:

- Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding
during participation in Study ALK9072-003EXT that was clinically relevant and related
to study drug

- Missed more than 1 scheduled study visit during participation in the preceding Study
ALK9072-003EXT

- Has a significant or unstable medical condition that would preclude safe completion
of the current study

- Subject is pregnant or breastfeeding

- Subject expects to be incarcerated, or has pending legal action which may impact
compliance with study participation or procedures
We found this trial at
15
sites
Atlanta, Georgia 30308
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Atlanta, GA
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Burgas,
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Chicago, Illinois 60611
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Chicago, IL
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Dallas, Texas 75231
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Dallas, TX
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Ft. Lauderdale, Florida 33308
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Ft. Lauderdale, FL
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Garden Grove, California 92845
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Garden Grove, CA
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Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Leesburg, Florida 34748
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Leesburg, FL
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Little Rock, Arkansas 72211
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Little Rock, AR
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Oakland, California 94612
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Oakland, CA
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Oceanside, California 92056
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Oceanside, CA
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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Orange, California 92868
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Orange, CA
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Shreveport, Louisiana 71101
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Shreveport, LA
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Washington, District of Columbia 20016
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Washington,
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