Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

February 8, 2024 updated by: Alkermes, Inc.

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

524

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

  • Austria
      • Vienna, Austria
        • Alkermes Investigational Site
  • Bulgaria
      • Burgas, 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
  • Ireland
      • Galway, Ireland
        • Alkermes Investigational Site
  • Israel
      • Jerusalem, Israel
        • Alkermes Investigational Site
      • Ramat Gan, Israel
        • Alkermes Investigational Site
  • Italy
      • Brescia, Italy
        • Alkermes Investigational Site
      • Napoli, Italy
        • Alkermes Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Alkermes Investigational Site
  • Poland
      • Poznań, Poland
        • Alkermes Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico
        • Alkermes Investigational Site
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Alkermes Investigational Site
      • Moscow, Russian Federation
        • Alkermes Investigational Site
      • Roshchino, Russian Federation
        • Alkermes Investigational Site
      • Rostov-on-Don, Russian Federation
        • Alkermes Investigational Site
      • Saint Petersburg, Russian Federation
        • Alkermes Investigational Site
      • Samara, Russian Federation
        • Alkermes Investigational Site
      • Saratow, Russian Federation
        • Alkermes Investigational Site
      • Tonnel'nyy, Russian Federation
        • Alkermes Investigational Site
  • Serbia
      • Belgrad, Serbia
        • Alkermes Investigational Site
      • Belgrade, Serbia
        • Alkermes Investigational Site
      • Kragujevac, Serbia
        • Alkermes Investigational Site
      • Novi Kneževac, Serbia
        • Alkermes Investigational Site
  • Ukraine
      • 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
      • Smila, Ukraine
        • Alkermes Investigational Site
      • Vinnytsia, Ukraine
        • Alkermes Investigational Site
  • United Kingdom
      • Headington, United Kingdom
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Alkermes Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • Alkermes Investigational Site
      • Cerritos, California, United States, 90703
        • Alkermes Investigational Site
      • Culver City, California, United States, 90230
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Glendale, California, United States, 91206
        • Alkermes Investigational Site
      • Long Beach, California, United States, 90822
        • Alkermes Investigational Site
      • Oakland, California, United States, 94607
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92056
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Palo Alto, California, United States, 94305
        • Alkermes Investigational Site
      • Pico Rivera, California, United States, 90660
        • Alkermes Investigational Site
      • Redlands, California, United States, 92374
        • Alkermes Investigational Site
      • San Diego, California, United States, 92013
        • Alkermes Investigational Site
      • Temecula, California, United States, 92591
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • Alkermes Investigational Site
    • Florida
      • Lauderhill, Florida, United States, 33319
        • Alkermes Investigational Site
      • North Miami, Florida, United States, 33161
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30331
        • Alkermes Investigational Site
      • Augusta, Georgia, United States, 30912
        • Alkermes Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Chicago, Illinois, United States, 60611
        • Alkermes Investigational Site
      • Winfield, Illinois, United States, 60190
        • Alkermes Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63118
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Alkermes Investigational Site
      • Marlton, New Jersey, United States, 08053
        • Alkermes Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Alkermes Investigational Site
      • Rochester, New York, United States, 14615
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • Alkermes Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77030
        • Alkermes Investigational Site
      • Richardson, Texas, United States, 75080
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • 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

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willing and able to give informed consent/assent as per local requirements
  • Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
  • Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
  • Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
  • Additional criteria may apply

Exclusion Criteria:

  • Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
  • Has a positive drug screen for drugs of abuse at study entry
  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
  • 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
Coated bilayer tablet
Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety will be measured by frequency of serious and non-serious adverse events
Time Frame: Up to 48 months
Up to 48 months

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body weight
Time Frame: Up to 48 months
Up to 48 months
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

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

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Alkermes Medical Director, 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)

June 15, 2017

Primary Completion (Actual)

September 6, 2023

Study Completion (Actual)

September 6, 2023

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK3831-A308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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