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NCT02873208 Clinical Trial

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02873208
Other study ID # ALK3831-A304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 7, 2016
Est. completion date October 17, 2019

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

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 266
Est. completion date October 17, 2019
Est. primary completion date October 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Agrees to use an acceptable method of contraception for the duration of the study - Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days - Additional criteria may apply Exclusion Criteria: - Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine - 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ALKS 3831
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan

Locations
Country Name City State
Puerto Rico Alkermes Investigational Site San Juan
Puerto Rico Alkermes Investigational Site San Juan
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 Austin Texas
United States Alkermes Investigational Site Bellevue Washington
United States Alkermes Investigational Site Berlin New Jersey
United States Alkermes Investigational Site Brooklyn New York
United States Alkermes Investigational Site Canton Ohio
United States Alkermes Investigational Site Cerritos California
United States Alkermes Investigational Site Chicago Illinois
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 Garden Grove California
United States Alkermes Investigational Site Glendale California
United States Alkermes Investigational Site Grand Rapids Michigan
United States Alkermes Investigational Site Hollywood Florida
United States Alkermes Investigational Site Houston Texas
United States Alkermes Investigational Site Jamaica New York
United States Alkermes Investigational Site Las Vegas Nevada
United States Alkermes Investigational Site Lauderhill Florida
United States Alkermes Investigational Site Lemon Grove California
United States Alkermes Investigational Site Little Rock Arkansas
United States Alkermes Investigational Site Long Beach California
United States Alkermes Investigational Site Marlton New Jersey
United States Alkermes Investigational Site North Miami Florida
United States Alkermes Investigational Site Oakland California
United States Alkermes Investigational Site Oceanside California
United States Alkermes Investigational Site Orange California
United States Alkermes Investigational Site Pico Rivera California
United States Alkermes Investigational Site Redlands California
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 Diego California
United States Alkermes Investigational Site Springdale Arkansas
United States Alkermes Investigational Site Temecula California
United States Alkermes Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Adverse Events Overall summary of treatment emergent adverse events during the treatment period Up to 52 weeks
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