A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
NCT ID: NCT03345979
Last Updated: 2020-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2017-11-15
2019-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group 1
Regular injections
Aripiprazole Lauroxil
Intramuscular injection; study drug provided using a pre-filled syringe
Treatment Group 2
Regular injections
Paliperidone Palmitate
Intramuscular injection
Interventions
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Aripiprazole Lauroxil
Intramuscular injection; study drug provided using a pre-filled syringe
Paliperidone Palmitate
Intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjeev Pathak, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Rogers, Arkansas, United States
Alkermes Investigational Site
Cerritos, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Lemon Grove, California, United States
Alkermes Investigational Site
Hialeah, Florida, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
Flowood, Mississippi, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Las Vegas, Nevada, United States
Alkermes Investigational Site
Berlin, New Jersey, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Garland, Texas, United States
Alkermes Investigational Site
Richardson, Texas, United States
Countries
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References
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Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
Citrome L, Yagoda S, Bidollari I, Wang M. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Psychiatry. 2024 Feb 28;85(1):23m15095. doi: 10.4088/JCP.23m15095.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK9072-A306
Identifier Type: -
Identifier Source: org_study_id
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