A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
NCT ID: NCT02636842
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2015-12-31
2016-06-30
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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Location
Deltoid or Gluteal Muscle
Aripiprazole Lauroxil
Intramuscular (IM) injection, single dose
Interventions
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Aripiprazole Lauroxil
Intramuscular (IM) injection, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has demonstrated ability to tolerate aripiprazole
* Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
* Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
* Additional criteria may apply
Exclusion Criteria
* Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
* Is a danger to himself/herself at screening or upon admission
* Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Has a positive urine drug screen at screening or Day 1
* 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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Robert Risinger, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Cerritos, California, United States
Alkermes Investigational Site
Lemon Grove, California, United States
Alkermes Investigational Site
Oakland, California, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
Marlton, New Jersey, United States
Alkermes Investigative Site
Dallas, Texas, United States
Countries
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Other Identifiers
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ALK9072-A106
Identifier Type: -
Identifier Source: org_study_id
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