A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT01626456 | Completed Phase 3 Results

• 1 other identifier: ALK9072-003EXT
• Study Type: interventional
• Target: 478
• Locations: 8 countries
• Sites: 82

Brief Summary

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

  This measure includes incidences \>5%.

  52 weeks

Secondary Outcomes (5)

• Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)

  52 weeks

• Discontinuation From Study Due to Adverse Events (AEs)

  52 weeks

• Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)

  52 weeks

• Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests

  52 weeks

• Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores

  52 weeks

Study Arms (2)

ALKS 9072, Low

EXPERIMENTAL

Drug: ALKS 9072, Low

ALKS 9072, High

EXPERIMENTAL

Drug: ALKS 9072, High

Interventions

ALKS 9072, Low DRUG

IM injection, given monthly

ALKS 9072, Low

ALKS 9072, High DRUG

IM injection, given monthly

ALKS 9072, High

Eligibility Criteria

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

You may qualify if:

• (Subjects who participated in ALK9072-003)
• 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

You may not qualify if:

• (Subjects who participated in ALK9072-003)
• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (82)

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

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

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, 60611, 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

Location

Alkermes Investigational Site

Rousse, Bulgaria

Location

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

Location

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

Location

Alkermes Investigational Site

Mandaluyong, Philippines

Location

Alkermes Investigational Site

Manila, Philippines

Location

Alkermes Investigational Site

Pasig, Philippines

Location

Alkermes Investigational Site

Târgu Mureş, Mureș County, Romania

Location

Alkermes Investigational Site

Bucharest, Romania

Location

Alkermes Investigational Site

Craiova, Romania

Location

Alkermes Investigational Site

Iași, Romania

Location

Alkermes Investigational Site

Oradea, Romania

Location

Alkermes Investigational Site

Nikol’skoye, Gatchinckiy, Russia

Location

Alkermes Investigational Site

Staritsa, Orenburg Oblast, Russia

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Alkermes Investigational Site

Khot'kovo, Russia

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Alkermes Investigational Site

Lipetsk, Russia

Location

Alkermes Investigational Site

Moscow, Russia

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Alkermes Investigational Site

Nizhny Novgorod, Russia

Location

Alkermes Investigational Site

Rostov-on-Don, Russia

Location

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

Talagi, 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

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Alkermes Investigational Site

Jeollanam-do, South Korea

Location

Alkermes Investigational Site

Seoul, South Korea

Location

Alkermes Investigational Site

Stepanivka, Kherson Oblast, Ukraine

Location

Alkermes Investigational Site

Chernihiv, Ukraine

Location

Alkermes Investigational Site

Donetsk, Ukraine

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Alkermes Investigational Site

Kharkiv, Ukraine

Location

Alkermes Investigational Site

Kyiv, Ukraine

Location

Alkermes Investigational Site

Luhansk, Ukraine

Location

Alkermes Investigational Site

Lviv, Ukraine

Location

Alkermes Investigational Site

Poltava, Ukraine

Location

Alkermes Investigational Site

Simferopol, Ukraine

Location

Alkermes Investigational Site

Ternopil, Ukraine

Location

Alkermes Investigational Site

Uzhhorod, Ukraine

Location

Alkermes Investigational Site

Vinnytsia, Ukraine

Location

Related Publications (5)

• 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

• 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.

  PMID: 33761928 DERIVED

• 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.

  PMID: 32841554 DERIVED

• 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.

  PMID: 30109845 DERIVED

• 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.

  PMID: 29941057 DERIVED

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.

usmedinfo@alkermes.com

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 22, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 25, 2018
• Results First Posted: October 27, 2016

Record last verified: 2018-08

Locations

KR (3); PH (6); RU (14); MY (4); BU (13); RO (5); UA (12); US (25)