A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
NCT ID: NCT01469039
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2011-12-31
2014-03-31
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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ALKS 9072
ALKS 9072
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
Placebo
Placebo
Placebo for IM injection, given monthly
Interventions
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ALKS 9072
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
Placebo
Placebo for IM injection, given monthly
Eligibility Criteria
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Inclusion Criteria
* Has been able to achieve outpatient status for more than 3 months in the past year
* Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
* Willing and able to be confined to an inpatient study unit for 2 weeks or longer
Exclusion Criteria
* History of treatment resistance
* Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Receipt of any antipsychotic medication by IM injection within 60 days before Screening
* Current involuntary hospitalization or incarceration
* Hospitalized for more than 30 days during the 90 days before Screening
18 Years
70 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
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Springdale, Arkansas, United States
Alkermes Investigational Site
Cerritos, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
La Habra, California, United States
Alkermes Investigational Site
Oakland, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Fort Lauderdale, Florida, United States
Alkermes Investigational site
Leesburg, 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
Overland Park, Kansas, United States
Alkermes Investigational Site
Rockville, Maryland, United States
Alkermes Investigational Site
Creve Coeur, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Charleston, South Carolina, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Burgas, , Bulgaria
Alkermes Investigational Site
Kazanlak, , Bulgaria
Alkermes Investigational Site
Novi Iskar, , Bulgaria
Alkermes Investigational Site
Pazardzhik, , Bulgaria
Alkermes Investigational Site
Pleven, , Bulgaria
Alkermes Investigational Site
Plovdiv, , Bulgaria
Alkermes Investigational Site
Radnevo, , Bulgaria
Alkermes Investigational Site
Rousse, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Stara Zagora, , Bulgaria
Alkermes Investigational Site
Targovishte, , Bulgaria
Alkermes Investigational Site
Veliko Tarnovo, , Bulgaria
Alkermes Investigational Site
Vratsa, , Bulgaria
Alkermes Investigational Site
Cheras, , Malaysia
Alkermes Investigational Site
Johor Bahru, , Malaysia
Alkermes Investigational Site
Kuala Lumpur, , Malaysia
Alkermes Investigational Site
Kuching, , Malaysia
Alkermes Investigational Site
Mariveles, Bataan, Philippines
Alkermes Investigational Site
Cebu City, , Philippines
Alkermes Investigational Site
Iloilo City, , Philippines
Alkermes Investigational Site
Mandaluyong, , Philippines
Alkermes Investigational Site
Manila, , Philippines
Alkermes Investigational Site
Pasig, , Philippines
Alkermes Investigational Site
Oradea, Bihor County, Romania
Alkermes Investigational Site
Bucharest, , Romania
Alkermes Investigational Site
Bucharest, , Romania
Alkermes Investigational Site
Craiova, , Romania
Alkermes Investigational Site
Iași, , Romania
Alkermes Investigational Site
Târgu Mureş, , Romania
Alkermes Investigational Site
Nikol’skoye, Gatchinckiy, Russia
Alkermes Investigational Site
Staritsa, Orenburg Oblast, Russia
Alkermes Investigational Site
Talagi, Primorskiy (Maritime) Kray, Russia
Alkermes Investigational Site
Khot'kovo, Sergievo-Posadskiy, Russia
Alkermes Investigational Site
Lipetsk, , Russia
Alkermes Investigational Site
Moscow, , Russia
Alkermes Investigational Site
Nizhny Novgorod, , Russia
Alkermes Investigational Site
Rostov-on-Don, , Russia
Alkermes Investigational Site
Saint Petersburg, , Russia
Alkermes Investigational Site
Samara, , Russia
Alkermes Investigational Site
Saratov, , Russia
Alkermes Investigational Site
Stavropol, , Russia
Alkermes Investigational Site
Voronezh, , Russia
Alkermes Investigational Site
Yaroslavl, , Russia
Alkermes Investigational Site
Jeju City, , South Korea
Alkermes Investigational Site
Jeollanam-do, , South Korea
Alkermes Investigational Site
Seoul, , South Korea
Alkermes Investigational Site
Stepanivka, Kherson Oblast, Ukraine
Alkermes Investigational Site
Chernihiv, , Ukraine
Alkermes Investigational Site
Donetsk, , Ukraine
Alkermes Investigational Site
Kharkiv, , Ukraine
Alkermes Investigational Site
Kyiv, , Ukraine
Alkermes Investigational Site
Luhansk, , Ukraine
Alkermes Investigational Site
Lviv, , Ukraine
Alkermes Investigational Site
Poltava, , Ukraine
Alkermes Investigational Site
Simferopol, , Ukraine
Alkermes Investigational Site
Ternopil, , Ukraine
Alkermes Investigational Site
Uzhhorod, , Ukraine
Alkermes Investigational Site
Vinnytsia, , Ukraine
Countries
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References
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Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
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.
Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
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.
McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.
Related Links
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Russian clinical trials website
EU Clinical Trials Register; EudraCT number 2012-003445-15
Other Identifiers
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ALK9072-003
Identifier Type: -
Identifier Source: org_study_id
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