A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT ID: NCT01626456
Last Updated: 2018-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2012-06-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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ALKS 9072, Low
ALKS 9072, Low
IM injection, given monthly
ALKS 9072, High
ALKS 9072, High
IM injection, given monthly
Interventions
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ALKS 9072, Low
IM injection, given monthly
ALKS 9072, High
IM injection, given monthly
Eligibility Criteria
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Inclusion Criteria
* Completed the ALK9072-003 Day 85 visit
* Continues to require treatment with an antipsychotic medication
(New Subjects)
* On a stable dose of oral antipsychotic medication
* Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
* Has been able to achieve outpatient status for more than 3 months prior to screening
* Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
Exclusion Criteria
* Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in study ALK9072-003
* Has a significant or unstable medical condition that would preclude safe completion of the current study
* Subject is pregnant or breastfeeding
* Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
(New Subjects)
* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
* Currently under involuntary hospitalization
* Current or expected incarceration
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
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
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
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
Târgu Mureş, Mureș County, Romania
Alkermes Investigational Site
Bucharest, , Romania
Alkermes Investigational Site
Craiova, , Romania
Alkermes Investigational Site
Iași, , Romania
Alkermes Investigational Site
Oradea, , Romania
Alkermes Investigational Site
Nikol’skoye, Gatchinckiy, Russia
Alkermes Investigational Site
Staritsa, Orenburg Oblast, Russia
Alkermes Investigational Site
Khot'kovo, , 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
Talagi, , 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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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.
McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.
Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.
Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.
Weiden PJ, Du Y, Liu CC, Stanford AD. Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period. CNS Spectr. 2019 Aug;24(4):419-425. doi: 10.1017/S1092852918000986. Epub 2018 Jun 26.
Other Identifiers
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ALK9072-003EXT
Identifier Type: -
Identifier Source: org_study_id
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