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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161718
• Other study ID #: ALK3831-401
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease
• Schizophrenia

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