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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02161718
Other study ID # ALK3831-401
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2014
Est. completion date February 1, 2017

Study information

Verified date September 2021
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date February 1, 2017
Est. primary completion date January 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
Samidorphan + olanzapine (ALKS 3831)
Oral tablet, taken once daily
Placebo + olanzapine
Oral tablet, taken once daily

Locations

Country Name City State
Bulgaria Alkermes Investigational Site Burgas
Bulgaria Alkermes Investigational Site Kazanlak
Bulgaria Alkermes Investigational Site Lovech
Bulgaria Alkermes Investigational Site Novi Iskar
Bulgaria Alkermes Investigational Site Sofia
Bulgaria Alkermes Investigational Site Tserova Koria
Bulgaria Alkermes Investigational Site Varna
Bulgaria Alkermes Investigational Site Varna
Bulgaria Alkermes Investigational Site Vratsa
Poland Alkermes Investigational Site Belchatow
Poland Alkermes Investigational Site Bialystok
Poland Alkermes Investigational Site Gdansk
Poland Alkermes Investigational Site Lublin
United States Alkermes Investigational Site Anaheim California
United States Alkermes Investigational Site Atlanta Georgia
United States Alkermes Investigational Site Augusta Georgia
United States Alkermes Investigational Site Austin Texas
United States Alkermes Investigational Site Bellevue Washington
United States Alkermes Investigational Site Cedarhurst New York
United States Alkermes Investigational Site Charleston South Carolina
United States Alkermes Investigational Site Charleston South Carolina
United States Alkermes Investigational Site Charleston South Carolina
United States Alkermes Investigational Site Chicago Illinois
United States Alkermes Investigational Site Claremont New Hampshire
United States Alkermes Investigational Site Creve Coeur Missouri
United States Alkermes Investigational Site Culver City California
United States Alkermes Investigational Site Dallas Texas
United States Alkermes Investigational Site Dayton Ohio
United States Alkermes Investigational Site Decatur Georgia
United States Alkermes Investigational Site DeSoto Texas
United States Alkermes Investigational Site Flowood Mississippi
United States Alkermes Investigational Site Fort Lauderdale Florida
United States Alkermes Investigational Site Garden Grove California
United States Alkermes Investigational Site Hoffman Estates Illinois
United States Alkermes Investigational Site Irvine California
United States Alkermes Investigational Site Jamaica New York
United States Alkermes Investigational Site Kansas City Missouri
United States Alkermes Investigational Site La Jolla California
United States Alkermes Investigational Site Las Vegas Nevada
United States Alkermes Investigational Site Leesburg Florida
United States Alkermes Investigational Site Little Rock Arkansas
United States Alkermes Investigational Site Long Beach California
United States Alkermes Investigational Site Maitland Florida
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Nashua New Hampshire
United States Alkermes Investigational Site National City California
United States Alkermes Investigational Site Neptune New Jersey
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site North Miami Florida
United States Alkermes Investigational Site Oak Brook Illinois
United States Alkermes Investigational Site Oakland California
United States Alkermes Investigational Site Oakland Park Florida
United States Alkermes Investigational Site Oceanside California
United States Alkermes Investigational Site Oklahoma City Oklahoma
United States Alkermes Investigational Site Orange California
United States Alkermes Investigational Site Orlando Florida
United States Alkermes Investigational Site Rochester New York
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site San Diego California
United States Alkermes Investigational Site San Francisco California
United States Alkermes Investigational Site Scranton Pennsylvania
United States Alkermes Investigational Site Shreveport Louisiana
United States Alkermes Investigational Site Springdale Arkansas
United States Alkermes Investigational Site Staten Island New York
United States Alkermes Investigational Site Tampa Florida
United States Alkermes Investigational Site Torrance California
United States Alkermes Investigational Site Washington District of Columbia
United States Alkermes Investigational Site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland, 

References & Publications (1)

Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Cli — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) 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):
Hospitalization (includes psychiatric& treatment of alcohol intoxication/withdrawal)
>= 25% or >= 15 point increase from randomization in PANSS total score
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 Number of Events of Exacerbation of Disease (EEDS) 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):
Hospitalization(includes psychiatric & treatment of alcohol intoxication/withdrawal)
>= 25% or >= 15 point increase from randomization in PANSS total score
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 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) 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
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