A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
NCT ID: NCT02634320
Last Updated: 2018-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2015-12-31
2017-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aripiprazole Lauroxil
Intramuscular (IM) injection
Aripiprazole Lauroxil
Monthly IM injection
Interventions
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Aripiprazole Lauroxil
Monthly IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of schizophrenia
* Is clinically stable
* Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
* Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
* Agreed to abide by the contraceptive requirements o the protocol
* Resides in a stable living situation
* Additional criteria may apply
Exclusion Criteria
* Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
* Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
* Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
* 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
Anaheim, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
National City, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
Panorama City, California, United States
Alkermes Investigational Site
Augusta, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Shreveport, Louisiana, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Garfield Heights, Ohio, United States
Alkermes Investigational Site
Lincoln, Rhode Island, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Countries
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References
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Opler MGA, Claxton A, McGrory J, Gasper S, Wang M, Yagoda S. Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. Innov Clin Neurosci. 2024 Mar 1;21(1-3):43-51. eCollection 2024 Jan-Mar.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK9072-A401
Identifier Type: -
Identifier Source: org_study_id
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