An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT01895452 | Completed Phase 3 Results

• 1 other identifier: ALK9072-003EXT2
• Study Type: interventional
• Target: 291
• Locations: 8 countries
• Sites: 57

Brief Summary

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

  This measure includes all incidences, including those that occurred \>5%.

  Up to 12 months

Secondary Outcomes (2)

• Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time

  Up to 12 months

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

  Up to 12 months

Study Arms (2)

ALKS 9072, Low Dose

EXPERIMENTAL

Drug: ALKS 9072, Low Dose

ALKS 9072, High Dose

EXPERIMENTAL

Drug: ALKS 9072, High Dose

Interventions

ALKS 9072, Low Dose DRUG

Intramuscular injection, given monthly

ALKS 9072, Low Dose

ALKS 9072, High Dose DRUG

Intramuscular injection, given monthly

ALKS 9072, High Dose

Eligibility Criteria

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

You may qualify if:

• Completed the treatment period of Study ALK9072-003EXT
• Continues to require chronic treatment with an antipsychotic medication
• Continues to reside in a stable living situation
• Continues to have an identified reliable informant

You may not qualify if:

• Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
• Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
• 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, or has pending legal action which may impact compliance with study participation or procedures

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (57)

Alkermes Investigational Site

Little Rock, Arkansas, 72201, United States

Location

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, 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

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

Shreveport, Louisiana, 71101, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73116, 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

Novi Iskar, Bulgaria

Location

Alkermes Investigational Site

Pazardzhik, Bulgaria

Location

Alkermes Investigational Site

Plovdiv, Bulgaria

Location

Alkermes Investigational Site

Sofia, 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 Lampur, 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

Bucharest, Romania

Location

Alkermes Investigational Site

Oradea, Romania

Location

Alkermes Investigational Site

Târgu Mureş, Romania

Location

Alkermes Investigational Site

Roshchino, Vyborgskiy, Russia

Location

Alkermes Investigational Site

Lipetsk, Russia

Location

Alkermes Investigational Site

Moscow, Russia

Location

Alkermes Investigational Site

Rostov-on-Don, Russia

Location

Alkermes Investigational Site

Saint Petersburg, Russia

Location

Roshchino township

Samara, Russia

Location

Roshchino township

Saratov, Russia

Location

Alkermes Investigational Site

Stavropol, Russia

Location

Alkermes Investigational Site

Talagi, Russia

Location

Alkermes Investigational Site

Yaroslavl, Russia

Location

Alkermes Investigational Site

Jeollanam-do, South Korea

Location

Alkermes Investigational Site

Chernihiv, Ukraine

Location

Alkermes Investigational Site

Donetsk, Ukraine

Location

Alkermes Investigational Site

Kharkiv, Ukraine

Location

Alkermes Investigational Site

Kherson, Ukraine

Location

Alkermes Investigational Site

Kyiv, Ukraine

Location

Alkermes Investigational Site

Lviv, Ukraine

Location

Alkermes Investigational Site

Poltava, Ukraine

Location

Alkermes Investigational Site

Ternopil, Ukraine

Location

Roshchino township

Vinnytsia, 61068, Ukraine

Location

Related Publications (2)

• 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

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

866-204-7823

Study Officials

• Robert Risinger, MD

  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: July 5, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2017
• Results First Posted: August 25, 2017

Record last verified: 2017-07

Locations

RU (10); MY (4); US (17); RO (3); KR (1); UA (9); BU (8); PH (5)