A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

July 15, 2019 updated by: Alkermes, Inc.

A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

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
      • Lovech, Bulgaria
        • Alkermes Investigational Site
      • Novi Iskar, Bulgaria
        • Alkermes Investigational Site
      • Plovdiv, Bulgaria
        • Alkermes Investigational Site
      • Sofia, Bulgaria
        • Alkermes Investigational Site
      • Tserova Koria, Bulgaria
        • Alkermes Investigational Site
      • Veliko Tarnovo, Bulgaria
        • Alkermes Investigational Site
      • Vratsa, Bulgaria
        • Alkermes Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Alkermes Investigational Site
      • Kragujevac, Serbia
        • Alkermes Investigational Site
      • Novi Knezevac, Serbia
        • Alkermes Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • Alkermes Investigational Site
      • Kiev, Ukraine
        • Alkermes Investigational Site
      • L'viv, Ukraine
        • Alkermes Investigational Site
      • Stepanovka, Ukraine
        • Alkermes Investigational Site
      • Vinnytsia, Ukraine
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Springdale, Arkansas, United States, 72764
        • Alkermes Investigational Site
    • California
      • Culver City, California, United States, 90230
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Lemon Grove, California, United States, 91945
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • San Diego, California, United States, 92103
        • Alkermes Investigational Site
    • Florida
      • Miami, Florida, United States, 33161
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Alkermes Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Texas
      • 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:

  • Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
  • Agrees to use an acceptable method of contraception for the duration of the study.
  • Additional criteria may apply.

Exclusion Criteria:

  • Subject is currently taking medications that are contraindicated with olanzapine use.
  • Subject has a positive test for drugs of abuse at study entry.
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study.
  • Additional 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 3831
Olanzapine + samidorphan; administered as a coated bilayer tablet.
Drug: ALKS 3831
Tablets were administered for daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

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

Sponsor

Alkermes, Inc.

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 (Actual)

January 20, 2016

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK3831-A306

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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