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:9/27/2018
Start Date:June 2012
End Date:April 2015

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

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.


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 of
Mental 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 Criteria:

(Subjects who participated in ALK9072-003)

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

- 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 of
the current study

- Subject is pregnant or breastfeeding

- Subject expects to be incarcerated in the next 12 months, or has pending legal action
which 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 days
prior to screening

- Currently under involuntary hospitalization

- Current or expected incarceration

Additional inclusion/exclusion criteria may apply
We found this trial at
27
sites
Philadelphia, Pennsylvania 19131
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Philadelphia, PA
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Atlanta, Georgia 30308
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Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Austin, Texas 78731
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Austin, TX
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Burgas,
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Charleston, South Carolina 29407
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Charleston, SC
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Chicago, Illinois 60611
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Chicago, IL
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Chicago, Illinois 60611
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Chicago, IL
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Creve Coeur, Missouri 63141
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Creve Coeur, MO
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Dallas, Texas 75231
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Dallas, TX
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Dallas, Texas 75231
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Dallas, TX
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Fort Lauderdale, Florida 33308
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Fort 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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La Habra, California 90631
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La Habra, CA
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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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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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Oceanside, California 92056
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Oceanside, CA
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Overland Park, Kansas 66212
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Overland Park, KS
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Rockville, Maryland 20850
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Rockville, MD
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Saint Louis, Missouri 63104
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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Springdale, Arkansas 72764
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Springdale, AR
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Washington, District of Columbia 20016
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Washington,
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