Clinical trial NCT02873208: A Phase 3, 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: 2016-08-19
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: 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:

* 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

Primary outcomes:
measure: Number of Subjects With Adverse Events
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: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
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: Glendale
country: United States
facility: Alkermes Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Long Beach
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: Redlands
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: Hollywood
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Grand Rapids
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: Creve Coeur
country: United States
facility: Alkermes Investigational Site
state: Missouri
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: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Alkermes Investigational Site
state: New York
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: Rochester
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: PRINCIPAL_INVESTIGATOR
References: