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NCT02669758 Clinical Trial

A 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 NCT02669758
Other study ID # ALK3831-A306
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 20, 2016
Est. completion date June 29, 2018

Study information
Verified date July 2019
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 281
Est. completion date June 29, 2018
Est. primary completion date June 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.

- Agrees to use an acceptable method of contraception for the duration of the study.

- Additional criteria may apply.

Exclusion Criteria:

- Subject is currently taking medications that are contraindicated with olanzapine use.

- 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
Tablets were administered for daily dosing

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 Plovdiv
Bulgaria Alkermes Investigational Site Sofia
Bulgaria Alkermes Investigational Site Tserova Koria
Bulgaria Alkermes Investigational Site Veliko Tarnovo
Bulgaria Alkermes Investigational Site Vratsa
Serbia Alkermes Investigational Site Belgrade
Serbia Alkermes Investigational Site Kragujevac
Serbia Alkermes Investigational Site Novi Knezevac
Ukraine Alkermes Investigational Site Kharkiv
Ukraine Alkermes Investigational Site Kiev
Ukraine Alkermes Investigational Site L'viv
Ukraine Alkermes Investigational Site Stepanovka
Ukraine Alkermes Investigational Site Vinnytsia
United States Alkermes Investigational Site Chicago Illinois
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 Garden Grove California
United States Alkermes Investigational Site Las Vegas Nevada
United States Alkermes Investigational Site Lemon Grove California
United States Alkermes Investigational Site Little Rock Arkansas
United States Alkermes Investigational Site Marlton New Jersey
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Orange California
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site San Diego California
United States Alkermes Investigational Site Springdale Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Serbia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) Up to 52 weeks
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