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

Alkermes

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: ALKS 9072

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01469039

ALK9072-003

Details and patient eligibility

About

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.

Enrollment

623 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.