Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Lead Sponsor:
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT01469039
Start Date
December 1 2011
End Date
March 1 2014
Last Update
January 30 2019
Active Locations (84)
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1
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72201
2
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
3
Alkermes Investigational Site
Springdale, Arkansas, United States, 72764
4
Alkermes Investigational Site
Cerritos, California, United States, 90703