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

August 28, 2018 updated by: Alkermes, Inc.

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

478

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
        • Alkermes Investigational Site
      • Craiova, Romania
        • Alkermes Investigational Site
      • Iasi, Romania
        • Alkermes Investigational Site
      • Oradea, Romania
        • Alkermes Investigational Site
    • Mures
      • Targu Mures, Mures, Romania
        • Alkermes Investigational Site
  • Russian Federation
      • Khotkovo, Russian Federation
        • Alkermes Investigational Site
      • 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
      • Talagi, 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
  • 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
      • Vinnytsia, 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
      • 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
      • 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
      • Chicago, Illinois, United States, 60611
        • 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:

(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

Exclusion Criteria:

(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

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 9072, Low
Drug: ALKS 9072, Low
IM injection, given monthly
Experimental: ALKS 9072, High
Drug: ALKS 9072, High
IM injection, given monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time Frame: 52 weeks
This measure includes incidences >5%.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
Time Frame: 52 weeks
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
52 weeks
Discontinuation From Study Due to Adverse Events (AEs)
Time Frame: 52 weeks
Number of subjects who discontinued the study due to AE.
52 weeks
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 52 weeks
The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
52 weeks
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Time Frame: 52 weeks
Includes incidence >2% but <5%.
52 weeks
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
Time Frame: 52 weeks
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
52 weeks

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

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

June 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK9072-003EXT

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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