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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01626456

Run by

Alkermes, Inc.

People needed

478

Starts

2012-06-01

Expected to finish

2015-04-01

Last updated by the study team

2018-09-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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

You may not qualify if…

• (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

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Springdale, Arkansas, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — La Habra, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Fort Lauderdale, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Overland Park, Kansas, United States
• Alkermes Investigational Site — Rockville, Maryland, United States
• Alkermes Investigational Site — Creve Coeur, Missouri, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Philadelphia, Pennsylvania, United States
• Alkermes Investigational Site — Charleston, South Carolina, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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