A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

Study Overview
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Brief Summary
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This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.

Official Title
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A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation

Conditions
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Schizophrenia

Intervention / Treatment
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* Combination Product: Aripiprazole Lauroxil
* Drug: Paliperidone Palmitate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a diagnosis of schizophrenia Requires acute treatment for symptoms of schizophrenia Willing and able to be confined to an inpatient study unit for up to 3-4 weeks Has experienced at least one previous hospitalization for schizophrenia Has been able to achieve outpatient status for more than 3 months in the past year Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2 Resides in a stable living situation when not hospitalized Has an identified reliable caregiver (for example, family member) Additional criteria may apply Exclusion Criteria: Poses a current suicide risk Pregnant, planning to become pregnant, or breastfeeding Initiated first antipsychotic treatment within the past 12 months Has received a long-acting injectable antipsychotic in the past 3 months Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product. A positive urine drug test for drugs of abuse Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment Group 1<br>Regular injections | Combination Product: Aripiprazole Lauroxil<br>* Intramuscular injection; study drug provided using a pre-filled syringe<br>* Other names: ARISTADA INITIO;|
| Active Comparator: Treatment Group 2<br>Regular injections | Drug: Paliperidone Palmitate<br>* Intramuscular injection<br>* Other names: Invega Sustenna;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. 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. | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). 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 | Baseline and 4 weeks | 
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. 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. | Baseline and 9 weeks | 
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. 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 | Baseline and 25 weeks | 
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).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 | Baseline and 9 weeks | 
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. 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 | Baseline and 25 weeks | 
| Number of Participants With Serious and Non-serious Adverse Events (AEs) |  | Up to 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, schizophrenia, aripiprazole lauroxil, ARISTADA, ARISTADA INITIO