A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

NCT01469039 | Completed Phase 3 Results DMC

• 1 other identifier: ALK9072-003
• Study Type: interventional
• Target: 623
• Locations: 8 countries
• Sites: 84

Brief Summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Conditions

Schizophrenia

Keywords

Alkermes; schizophrenia; ALKS 9072; ALKS 9070; aripiprazole lauroxil

Outcome Measures

Primary Outcomes (1)

• The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

  Data collected from baseline to day 85

Secondary Outcomes (1)

• Clinical Global Impression - Improvement (CGI-I) Scores at Day 85

  85 Days

Study Arms (2)

ALKS 9072

EXPERIMENTAL

Drug: ALKS 9072

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALKS 9072 DRUG

Intramuscular (IM) injection, 441 mg or 882 mg given monthly

ALKS 9072

Placebo DRUG

Placebo for IM injection, given monthly

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia according to DSM-IV-TR 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

You may not qualify if:

• History of poor or inadequate clinical response to treatment with aripiprazole
• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (84)

Alkermes Investigational Site

Little Rock, Arkansas, 72201, United States

Location

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Springdale, Arkansas, 72764, United States

Location

Alkermes Investigational Site

Cerritos, California, 90703, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

La Habra, California, 90631, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

San Diego, California, 92123, United States

Location

Alkermes Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Alkermes Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

Alkermes Investigational site

Leesburg, Florida, 34748, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30308, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Location

Alkermes Investigational Site

Rockville, Maryland, 20850, United States

Location

Alkermes Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63118, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Alkermes Investigational Site

Charleston, South Carolina, 29407, United States

Location

Alkermes Investigational Site

Austin, Texas, 78731, United States

Location

Alkermes Investigational Site

Austin, Texas, 78754, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75231, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75243, United States

Location

Alkermes Investigational Site

Burgas, Bulgaria

Location

Alkermes Investigational Site

Kazanlak, Bulgaria

Location

Alkermes Investigational Site

Novi Iskar, Bulgaria

Location

Alkermes Investigational Site

Pazardzhik, Bulgaria

Location

Alkermes Investigational Site

Pleven, Bulgaria

Location

Alkermes Investigational Site

Plovdiv, Bulgaria

Location

Alkermes Investigational Site

Radnevo, Bulgaria

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Alkermes Investigational Site

Rousse, Bulgaria

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Alkermes Investigational Site

Sofia, Bulgaria

Location

Alkermes Investigational Site

Stara Zagora, Bulgaria

Location

Alkermes Investigational Site

Targovishte, Bulgaria

Location

Alkermes Investigational Site

Veliko Tarnovo, Bulgaria

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Alkermes Investigational Site

Vratsa, Bulgaria

Location

Alkermes Investigational Site

Cheras, Malaysia

Location

Alkermes Investigational Site

Johor Bahru, Malaysia

Location

Alkermes Investigational Site

Kuala Lumpur, Malaysia

Location

Alkermes Investigational Site

Kuching, Malaysia

Location

Alkermes Investigational Site

Mariveles, Bataan, Philippines

Location

Alkermes Investigational Site

Cebu City, Philippines

Location

Alkermes Investigational Site

Iloilo City, Philippines

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Alkermes Investigational Site

Mandaluyong, Philippines

Location

Alkermes Investigational Site

Manila, Philippines

Location

Alkermes Investigational Site

Pasig, Philippines

Location

Alkermes Investigational Site

Oradea, Bihor County, Romania

Location

Alkermes Investigational Site

Bucharest, 030455, Romania

Location

Alkermes Investigational Site

Bucharest, Romania

Location

Alkermes Investigational Site

Craiova, Romania

Location

Alkermes Investigational Site

Iași, Romania

Location

Alkermes Investigational Site

Târgu Mureş, Romania

Location

Alkermes Investigational Site

Nikol’skoye, Gatchinckiy, Russia

Location

Alkermes Investigational Site

Staritsa, Orenburg Oblast, Russia

Location

Alkermes Investigational Site

Talagi, Primorskiy (Maritime) Kray, Russia

Location

Alkermes Investigational Site

Khot'kovo, Sergievo-Posadskiy, Russia

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Alkermes Investigational Site

Lipetsk, Russia

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Alkermes Investigational Site

Moscow, Russia

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Alkermes Investigational Site

Nizhny Novgorod, Russia

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Alkermes Investigational Site

Rostov-on-Don, Russia

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Alkermes Investigational Site

Saint Petersburg, Russia

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Alkermes Investigational Site

Samara, Russia

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Alkermes Investigational Site

Saratov, Russia

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Alkermes Investigational Site

Stavropol, Russia

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Alkermes Investigational Site

Voronezh, Russia

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Alkermes Investigational Site

Yaroslavl, Russia

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Alkermes Investigational Site

Jeju City, South Korea

Location

Alkermes Investigational Site

Jeollanam-do, South Korea

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Alkermes Investigational Site

Seoul, South Korea

Location

Alkermes Investigational Site

Stepanivka, Kherson Oblast, Ukraine

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Alkermes Investigational Site

Chernihiv, Ukraine

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Alkermes Investigational Site

Donetsk, Ukraine

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Alkermes Investigational Site

Kharkiv, Ukraine

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Alkermes Investigational Site

Kyiv, Ukraine

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Alkermes Investigational Site

Luhansk, Ukraine

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Alkermes Investigational Site

Lviv, Ukraine

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Alkermes Investigational Site

Poltava, Ukraine

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Alkermes Investigational Site

Simferopol, Ukraine

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Alkermes Investigational Site

Ternopil, Ukraine

Location

Alkermes Investigational Site

Uzhhorod, Ukraine

Location

Alkermes Investigational Site

Vinnytsia, Ukraine

Location

Related Publications (11)

• 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.

  PMID: 27707530 RESULT

• 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.

  PMID: 27574838 RESULT

• 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.

  PMID: 26517202 RESULT

• 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.

  PMID: 26114240 RESULT

• 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.

  PMID: 28342578 RESULT

• 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.

  PMID: 28712616 RESULT

• 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.

  PMID: 28625204 RESULT

• 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.

  PMID: 28350572 RESULT

• 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.

  PMID: 29179595 RESULT

• 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.

  PMID: 39145678 DERIVED

• 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.

  PMID: 28937706 DERIVED

Related Links

• Russian clinical trials website
• EU Clinical Trials Register; EudraCT number 2012-003445-15

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: ARISTADA Medical Information
• Organization: Alkermes, Inc.

866-274-7823

Study Officials

• Alkermes Medical Director

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 30, 2019
• Results First Posted: January 22, 2016

Record last verified: 2019-01

Locations

UA (12); KR (3); PH (6); MY (4); BU (13); US (26); RO (6); RU (14)