Clinical trial NCT02669758: A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Official title: A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Alkermes
ALKS 3831
Samidorphan
Schizophrenia
Safety
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Burgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Lovech
country: Bulgaria
facility: Alkermes Investigational Site
city: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Plovdiv
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Tserova Koria
country: Bulgaria
facility: Alkermes Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratsa
country: Bulgaria
facility: Alkermes Investigational Site
city: Belgrade
country: Serbia
facility: Alkermes Investigational Site
city: Kragujevac
country: Serbia
facility: Alkermes Investigational Site
city: Novi Knezevac
country: Serbia
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Kiev
country: Ukraine
facility: Alkermes Investigational Site
city: L'viv
country: Ukraine
facility: Alkermes Investigational Site
city: Stepanovka
country: Ukraine
facility: Alkermes Investigational Site
city: Vinnytsia
country: Ukraine
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References: