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

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ClinicalTrials.gov Identifier: NCT03345979

Recruitment Status : Completed

First Posted : November 17, 2017

Results First Posted : August 11, 2020

Last Update Posted : August 11, 2020

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Alkermes, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Combination Product: Aripiprazole Lauroxil Drug: Paliperidone Palmitate	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	November 15, 2017
Actual Primary Completion Date :	March 12, 2019
Actual Study Completion Date :	March 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole Paliperidone Paliperidone Palmitate Aripiprazole lauroxil

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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 Name: Invega Sustenna

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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
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.
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
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
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
Number of Participants With Serious and Non-serious Adverse Events (AEs) [ Time Frame: Up to 25 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345979

Locations

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

Sponsors and Collaborators

Alkermes, Inc.

Investigators

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Study Director:	Sanjeev Pathak, MD	Alkermes, Inc.

Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:

Study Protocol [PDF] January 4, 2018

Statistical Analysis Plan [PDF] February 5, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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Responsible Party:	Alkermes, Inc.
ClinicalTrials.gov Identifier:	NCT03345979
Other Study ID Numbers:	ALK9072-A306
First Posted:	November 17, 2017 Key Record Dates
Results First Posted:	August 11, 2020
Last Update Posted:	August 11, 2020
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	Yes

Keywords provided by Alkermes, Inc.:


Alkermes schizophrenia aripiprazole lauroxil ARISTADA ARISTADA INITIO

Additional relevant MeSH terms:

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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Aripiprazole Paliperidone Palmitate Aripiprazole lauroxil Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs	Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists

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