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

July 29, 2020 updated by: Alkermes, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Alkermes Investigational Site
    • California
      • Cerritos, California, United States, 90703
        • Alkermes Investigational Site
      • Culver City, California, United States, 90230
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Lemon Grove, California, United States, 91945
        • Alkermes Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Hoffman Estates, Illinois, United States, 60169
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78754
        • Alkermes Investigational Site
      • Garland, Texas, United States, 75042
        • Alkermes Investigational Site
      • Richardson, Texas, United States, 75080
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1
Regular injections
Combination product: Aripiprazole Lauroxil
Intramuscular injection; study drug provided using a pre-filled syringe
Other Names:
  • ARISTADA
  • ARISTADA INITIO
Active Comparator: Treatment Group 2
Regular injections
Drug: Paliperidone Palmitate
Intramuscular injection
Other Names:
  • Invega Sustenna

What is the study measuring?

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
Time Frame: Baseline and 4 weeks
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
Time Frame: Baseline and 4 weeks
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
Time Frame: Baseline and 9 weeks
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
Time Frame: Baseline and 25 weeks
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
Time Frame: Baseline and 9 weeks
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
Time Frame: Baseline and 25 weeks
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)
Time Frame: Up to 25 weeks
Up to 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

March 12, 2019

Study Completion (Actual)

March 12, 2019

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK9072-A306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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