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

January 14, 2019 updated by: Alkermes, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • 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
      • Ruse, 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
  • Korea, Republic of
      • Jeju-si, Korea, Republic of
        • Alkermes Investigational Site
      • Jeollanam-do, Korea, Republic of
        • Alkermes Investigational Site
      • Seoul, Korea, Republic of
        • Alkermes Investigational Site
  • Malaysia
      • Cheras, Malaysia
        • Alkermes Investigational Site
      • Johor Bahru, Malaysia
        • Alkermes Investigational Site
      • Kuala Lumpur, Malaysia
        • Alkermes Investigational Site
      • Kuching, Malaysia
        • Alkermes Investigational Site
  • Philippines
      • Cebu City, Philippines
        • Alkermes Investigational Site
      • Iloilo City, Philippines
        • Alkermes Investigational Site
      • Mandaluyong City, Philippines
        • Alkermes Investigational Site
      • Manila, Philippines
        • Alkermes Investigational Site
      • Pasig City, Philippines
        • Alkermes Investigational Site
    • Bataan
      • Mariveles, Bataan, Philippines
        • Alkermes Investigational Site
  • Romania
      • Bucharest, Romania, 030455
        • Alkermes Investigational Site
      • Bucharest, Romania
        • Alkermes Investigational Site
      • Craiova, Romania
        • Alkermes Investigational Site
      • Iasi, Romania
        • Alkermes Investigational Site
      • Targu Mures, Romania
        • Alkermes Investigational Site
    • Bihor
      • Oradea, Bihor, Romania
        • Alkermes Investigational Site
  • Russian Federation
      • Lipetsk, Russian Federation
        • Alkermes Investigational Site
      • Moscow, Russian Federation
        • Alkermes Investigational Site
      • Nizhniy Novgorod, Russian Federation
        • Alkermes Investigational Site
      • Rostov-on-Don, Russian Federation
        • Alkermes Investigational Site
      • Samara, Russian Federation
        • Alkermes Investigational Site
      • Saratov, Russian Federation
        • Alkermes Investigational Site
      • St. Petersburg, Russian Federation
        • Alkermes Investigational Site
      • Stavropol, Russian Federation
        • Alkermes Investigational Site
      • Voronezh, Russian Federation
        • Alkermes Investigational Site
      • Yaroslavl, Russian Federation
        • Alkermes Investigational Site
    • Gatchinckiy
      • Nikol'skoye, Gatchinckiy, Russian Federation
        • Alkermes Investigational Site
    • Orenburg
      • Staritsa, Orenburg, Russian Federation
        • Alkermes Investigational Site
    • Primorsky
      • Talagi, Primorsky, Russian Federation
        • Alkermes Investigational Site
    • Sergievo-Posadskiy
      • Khotkovo, Sergievo-Posadskiy, Russian Federation
        • Alkermes Investigational Site
  • Ukraine
      • Chernigiv, Ukraine
        • Alkermes Investigational Site
      • Donetsk, Ukraine
        • Alkermes Investigational Site
      • Kharkiv, Ukraine
        • Alkermes Investigational Site
      • Kyiv, Ukraine
        • Alkermes Investigational Site
      • Lugansk, Ukraine
        • Alkermes Investigational Site
      • Lviv, Ukraine
        • Alkermes Investigational Site
      • Poltava, Ukraine
        • Alkermes Investigational Site
      • Simferopol, Ukraine
        • Alkermes Investigational Site
      • Ternopil, Ukraine
        • Alkermes Investigational Site
      • Uzhgorod, Ukraine
        • Alkermes Investigational Site
      • Vinnytsya, Ukraine
        • Alkermes Investigational Site
    • Kherson
      • Stepanovka, Kherson, Ukraine
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Alkermes Investigational Site
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Springdale, Arkansas, United States, 72764
        • Alkermes Investigational Site
    • California
      • Cerritos, California, United States, 90703
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • La Habra, California, United States, 90631
        • Alkermes Investigational Site
      • Oakland, California, United States, 94612
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92056
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • San Diego, California, United States, 92123
        • Alkermes Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Alkermes Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Alkermes Investigational Site
      • Leesburg, Florida, United States, 34748
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Hoffman Estates, Illinois, United States, 60169
        • Alkermes Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Alkermes Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Alkermes Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63118
        • Alkermes Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Alkermes Investigational Site
      • Austin, Texas, United States, 78754
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75231
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75243
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Additional inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo for IM injection, given monthly
Experimental: ALKS 9072
Drug: ALKS 9072
Intramuscular (IM) injection, 441 mg or 882 mg given monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Data collected from baseline to day 85
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
Time Frame: 85 Days
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".
85 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK9072-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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