A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Key facts

Study ID

NCT01469039

Run by

Alkermes, Inc.

People needed

623

Starts

2011-12-01

Expected to finish

2014-03-01

Last updated by the study team

2019-01-30

Who can join

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

You may qualify if…

• Diagnosis of schizophrenia according to DSM-IV-TR criteria
• Has been able to achieve outpatient status for more than 3 months in the past year
• Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
• Resides in a stable living situation
• Willing and able to be confined to an inpatient study unit for 2 weeks or longer

You may not qualify if…

• History of poor or inadequate clinical response to treatment with aripiprazole
• History of treatment resistance
• Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
• Diagnosis of current substance dependence (including alcohol)
• Pregnant, lactating, or breastfeeding
• Receipt of any antipsychotic medication by IM injection within 60 days before Screening
• Current involuntary hospitalization or incarceration
• Hospitalized for more than 30 days during the 90 days before Screening
• 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 — Cerritos, California, 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 — Orange, 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 — 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 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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