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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALKS 9072
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 9072<br> | Drug: ALKS 9072<br>* Intramuscular (IM) injection, 441 mg or 882 mg given monthly<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo for IM injection, given monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | Data collected from baseline to day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement (CGI-I) Scores at Day 85 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. | 85 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, schizophrenia, ALKS 9072, ALKS 9070, aripiprazole lauroxil