A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

September 14, 2021 updated by: Alkermes, Inc.

A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

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, 8000
        • Alkermes Investigational Site
      • Kazanlak, Bulgaria, 6100
        • Alkermes Investigational Site
      • Lovech, Bulgaria, 5500
        • Alkermes Investigational Site
      • Novi Iskar, Bulgaria, 1282
        • Alkermes Investigational Site
      • Sofia, Bulgaria, 1606
        • Alkermes Investigational Site
      • Tserova Koria, Bulgaria, 8260
        • Alkermes Investigational Site
      • Varna, Bulgaria, 9020
        • Alkermes Investigational Site
      • Varna, Bulgaria, 9002
        • Alkermes Investigational Site
      • Vratsa, Bulgaria, 3000
        • Alkermes Investigational Site
  • Poland
      • Belchatow, Poland, 97-400
        • Alkermes Investigational Site
      • Bialystok, Poland, 15-464
        • Alkermes Investigational Site
      • Gdansk, Poland, 80-546
        • Alkermes Investigational Site
      • Lublin, Poland, 20-109
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Springdale, Arkansas, United States, 72764
        • Alkermes Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • Alkermes Investigational Site
      • Culver City, California, United States, 90230
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Irvine, California, United States, 92617
        • Alkermes Investigational Site
      • La Jolla, California, United States, 92037
        • Alkermes Investigational Site
      • Long Beach, California, United States, 90822
        • Alkermes Investigational Site
      • National City, California, United States, 91950
        • 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
      • San Francisco, California, United States, 94121
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • 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
      • Maitland, Florida, United States, 32751
        • Alkermes Investigational Site
      • Miami, Florida, United States, 33136
        • Alkermes Investigational Site
      • Miami, Florida, United States, 33122
        • Alkermes Investigational Site
      • North Miami, Florida, United States, 33021
        • Alkermes Investigational Site
      • Oakland Park, Florida, United States, 33334
        • Alkermes Investigational Site
      • Orlando, Florida, United States, 32803
        • Alkermes Investigational Site
      • Tampa, Florida, United States, 33613
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • 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
      • Hoffman Estates, Illinois, United States, 60169
        • Alkermes Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Alkermes Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Alkermes Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Kansas City, Missouri, United States, 64108
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63118
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Hampshire
      • Claremont, New Hampshire, United States, 03743
        • Alkermes Investigational Site
      • Nashua, New Hampshire, United States, 03060
        • Alkermes Investigational Site
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Alkermes Investigational Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Alkermes Investigational Site
      • Jamaica, New York, United States, 11423
        • Alkermes Investigational Site
      • New York, New York, United States, 10032
        • Alkermes Investigational Site
      • New York, New York, United States, 10021
        • Alkermes Investigational Site
      • New York, New York, United States, 10035
        • Alkermes Investigational Site
      • Rochester, New York, United States, 14642
        • Alkermes Investigational Site
      • Staten Island, New York, United States, 10312
        • Alkermes Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Alkermes Investigational Site
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18503
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Alkermes Investigational Site
      • Charleston, South Carolina, United States, 29425
        • Alkermes Investigational Site
      • Charleston, South Carolina, United States, 29401
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78754
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75214
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a BMI between 18.0 and 40.0 kg/m2, inclusive
  • Has a diagnosis of schizophrenia
  • Has a diagnosis of alcohol use disorder (AUD)
  • Has experienced an acute exacerbation of schizophrenia within the past 6 months
  • Additional criteria may apply

Exclusion Criteria:

  • Is pregnant or breastfeeding
  • Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
  • Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
  • Has current or pending legal charges with the potential for incarceration
  • Has a positive drug screen for opiates
  • 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Samidorphan + olanzapine (ALKS 3831)
Active study drug
Drug: Samidorphan + olanzapine (ALKS 3831)
Oral tablet, taken once daily
PLACEBO_COMPARATOR: Placebo + olanzapine
Drug: Placebo + olanzapine
Oral tablet, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
Time Frame: Up to 15 months

EEDS was defined as any of the following occurring during the double-blind period & was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):

  1. Hospitalization (includes psychiatric& treatment of alcohol intoxication/withdrawal)
  2. >= 25% or >= 15 point increase from randomization in PANSS total score
  3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:

3a. Score >= 5 for subjects at a 2nd ad hoc visit with a score <=3 at randomization 3b. Score >= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease
Up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Events of Exacerbation of Disease (EEDS)
Time Frame: Up to 15 months

EEDS was defined as any of the following occurring during the double-blind period & was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):

  1. Hospitalization(includes psychiatric & treatment of alcohol intoxication/withdrawal)
  2. >= 25% or >= 15 point increase from randomization in PANSS total score
  3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:

3a. Score >= 5 for subjects at a 2nd ad hoc visit with a score <=3 at randomization 3b. Score >= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease
Up to 15 months
Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27)
Time Frame: 24 weeks

Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days)

WHO criteria for risk of alcohol consumption on a single drinking day:

Abstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: >= 101 g; Females: >= 61 g
24 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 (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

January 11, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (ESTIMATE)

June 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK3831-401

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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