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
Atlanta, Georgia 30308
1919
mi
from 91732
Atlanta, GA
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Austin, Texas 78731
1212
mi
from 91732
Austin, TX
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Austin, Texas 78731
1212
mi
from 91732
Austin, TX
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6712
mi
from 91732
Burgas,
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Charleston, South Carolina 29407
2184
mi
from 91732
Charleston, SC
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Chicago, Illinois 60611
1729
mi
from 91732
Chicago, IL
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Chicago, Illinois 60611
1729
mi
from 91732
Chicago, IL
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Creve Coeur, Missouri 63141
1561
mi
from 91732
Creve Coeur, MO
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
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Garden Grove, California 92845
19
mi
from 91732
Garden Grove, CA
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Hoffman Estates, Illinois 60169
1706
mi
from 91732
Hoffman Estates, IL
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La Habra, California 90631
10
mi
from 91732
La Habra, CA
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Leesburg, Florida 34748
2149
mi
from 91732
Leesburg, FL
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Little Rock, Arkansas 72211
1463
mi
from 91732
Little Rock, AR
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Little Rock, Arkansas 72211
1463
mi
from 91732
Little Rock, AR
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Oakland, California 94612
351
mi
from 91732
Oakland, CA
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Oceanside, California 92056
73
mi
from 91732
Oceanside, CA
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Oceanside, California 92056
73
mi
from 91732
Oceanside, CA
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Overland Park, Kansas 66212
1335
mi
from 91732
Overland Park, KS
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Philadelphia, Pennsylvania 19131
2375
mi
from 91732
Philadelphia, PA
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Rockville, Maryland 20850
2274
mi
from 91732
Rockville, MD
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Saint Louis, Missouri 63104
1573
mi
from 91732
Saint Louis, MO
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San Diego, California 92123
100
mi
from 91732
San Diego, CA
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Springdale, Arkansas 72764
1354
mi
from 91732
Springdale, AR
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Washington, District of Columbia 20016
2281
mi
from 91732
Washington,
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