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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
623

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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