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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole Lauroxil
Paliperidone Palmitate
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Alkermes, schizophrenia, aripiprazole lauroxil, ARISTADA, ARISTADA INITIO

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Arm Description

Regular injections

Regular injections

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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
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
Number of Participants With Serious and Non-serious Adverse Events (AEs)

Full Information

First Posted
November 14, 2017
Last Updated
July 29, 2020
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03345979
Brief Title
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
March 12, 2019 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Alkermes, schizophrenia, aripiprazole lauroxil, ARISTADA, ARISTADA INITIO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Regular injections
Arm Title
Treatment Group 2
Arm Type
Active Comparator
Arm Description
Regular injections
Intervention Type
Combination Product
Intervention Name(s)
Aripiprazole Lauroxil
Other Intervention Name(s)
ARISTADA, ARISTADA INITIO
Intervention Description
Intramuscular injection; study drug provided using a pre-filled syringe
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate
Other Intervention Name(s)
Invega Sustenna
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Description
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
Time Frame
Baseline and 4 weeks
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Description
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.
Time Frame
Baseline and 9 weeks
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Description
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
Time Frame
Baseline and 25 weeks
Title
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Description
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
Time Frame
Baseline and 9 weeks
Title
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Description
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
Time Frame
Baseline and 25 weeks
Title
Number of Participants With Serious and Non-serious Adverse Events (AEs)
Time Frame
Up to 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Pathak, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Alkermes Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Alkermes Investigational Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Alkermes Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Alkermes Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alkermes Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Alkermes Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Alkermes Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34625041
Citation
Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x.
Results Reference
derived
PubMed Identifier
32433835
Citation
Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207.
Results Reference
derived

Learn more about this trial

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

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