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

July 25, 2017 updated by: Alkermes, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

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
      • Novi Iskar, Bulgaria
        • Alkermes Investigational Site
      • Pazardzhik, Bulgaria
        • Alkermes Investigational Site
      • Plovdiv, Bulgaria
        • Alkermes Investigational Site
      • Sofia, Bulgaria
        • Alkermes Investigational Site
      • Targovishte, Bulgaria
        • Alkermes Investigational Site
      • Veliko Tarnovo, Bulgaria
        • Alkermes Investigational Site
      • Vratsa, Bulgaria
        • Alkermes Investigational Site
  • Korea, Republic of
      • Jeollanam-do, Korea, Republic of
        • Alkermes Investigational Site
  • Malaysia
      • Cheras, Malaysia
        • Alkermes Investigational Site
      • Johor Bahru, Malaysia
        • Alkermes Investigational Site
      • Kuala Lampur, 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
    • Bataan
      • Mariveles, Bataan, Philippines
        • Alkermes Investigational Site
  • Romania
      • Bucharest, Romania
        • Alkermes Investigational Site
      • Oradea, Romania
        • Alkermes Investigational Site
      • Targu Mures, Romania
        • Alkermes Investigational Site
  • Russian Federation
      • Lipetsk, Russian Federation
        • Alkermes Investigational Site
      • Moscow, Russian Federation
        • Alkermes Investigational Site
      • Rostov-on-Don, Russian Federation
        • Alkermes Investigational Site
      • Samara, Russian Federation
        • Roshchino township
      • Saratov, Russian Federation
        • Roshchino township
      • St. Petersburg, Russian Federation
        • Alkermes Investigational Site
      • Stavropol, Russian Federation
        • Alkermes Investigational Site
      • Talagi, Russian Federation
        • Alkermes Investigational Site
      • Yaroslavl, Russian Federation
        • Alkermes Investigational Site
    • Vyborgskiy
      • Roshchino, Vyborgskiy, Russian Federation
        • Alkermes Investigational Site
  • Ukraine
      • Chernigiv, Ukraine
        • Alkermes Investigational Site
      • Donetsk, Ukraine
        • Alkermes Investigational Site
      • Kharkiv, Ukraine
        • Alkermes Investigational Site
      • Kherson, Ukraine
        • Alkermes Investigational Site
      • Kyiv, Ukraine
        • Alkermes Investigational Site
      • Lviv, Ukraine
        • Alkermes Investigational Site
      • Poltava, Ukraine
        • Alkermes Investigational Site
      • Ternopil, Ukraine
        • Alkermes Investigational Site
      • Vinnytsia, Ukraine, 61068
        • Roshchino township
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Alkermes Investigational Site
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
    • California
      • Garden Grove, California, United States, 92845
        • 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
    • District of Columbia
      • Washington, D.C., 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
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Alkermes Investigational Site
    • Texas
      • 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:

  • 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

Exclusion Criteria:

  • 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

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
Experimental: ALKS 9072, Low Dose
Drug: ALKS 9072, Low Dose
Intramuscular injection, given monthly
Experimental: ALKS 9072, High Dose
Drug: ALKS 9072, High Dose
Intramuscular injection, given monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
This measure includes all incidences, including those that occurred >5%.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
Time Frame: Up to 12 months
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); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Up to 12 months
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
Time Frame: Up to 12 months
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. Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Up to 12 months

Collaborators and Investigators

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

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Robert Risinger, MD, 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

July 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK9072-003EXT2

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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