An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
NCT ID: NCT02320032
Last Updated: 2018-08-29
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
140 participants
INTERVENTIONAL
2014-12-31
2016-04-30
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
NONE
Study Groups
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Aripiprazole Lauroxil - A
Intramuscular (IM) injection Dose and Dosing Sequence A
Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks
Aripiprazole Lauroxil - B
Intramuscular (IM) injection Dose and Dosing Sequence B
Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks
Aripiprazole Lauroxil - C
Intramuscular (IM) injection Dose and Dosing Sequence C
Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks
Aripiprazole Lauroxil - D
Intramuscular (IM) injection Dose and Dosing Sequence D
Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks
Interventions
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Aripiprazole Lauroxil
Gluteal IM injection, given once every 4 to 8 weeks
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 35.0 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
* 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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Alkermes Medical Director, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Cerritos, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
Maitland, Florida, United States
Alkermes Investigational Site
Oakland Park, Florida, United States
Alkermes Investigational Site
Tampa, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Marlton, New Jersey, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Countries
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References
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Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.
Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.
Other Identifiers
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ALK9072-A105
Identifier Type: -
Identifier Source: org_study_id
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