Clinical trial NCT03201757: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Official title: A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizophreniform Disorder
Bipolar I Disorder
Keywords: Alkermes
ALKS 3831
Olanzapine
Samidorphan
Schizophrenia
Schizophreniform
Bipolar I
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 523
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent/assent as per local requirements
* Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
* Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
* Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
* Additional criteria may apply

Exclusion Criteria:

* Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
* Has a positive drug screen for drugs of abuse at study entry
* Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
* Additional criteria may apply

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 48 months
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
timeFrame: Up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Rogers
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: 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: Palo Alto
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: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
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: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
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: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Winfield
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: Kansas City
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
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: Rochester
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Richardson
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Vienna
country: Austria
facility: Alkermes Investigational Site
city: Burgas
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: Galway
country: Ireland
facility: Alkermes Investigational Site
city: Jerusalem
country: Israel
facility: Alkermes Investigational Site
city: Ramat Gan
country: Israel
facility: Alkermes Investigational Site
city: Brescia
country: Italy
facility: Alkermes Investigational Site
city: Napoli
country: Italy
facility: Alkermes Investigational Site
city: Busan
country: Korea, Republic of
facility: Alkermes Investigational Site
city: Poznań
country: Poland
facility: Alkermes Investigational Site
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
city: Arkhangel'sk
country: Russian Federation
facility: Alkermes Investigational Site
city: Moscow
country: Russian Federation
facility: Alkermes Investigational Site
city: Roshchino
country: Russian Federation
facility: Alkermes Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Alkermes Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Alkermes Investigational Site
city: Samara
country: Russian Federation
facility: Alkermes Investigational Site
city: Saratow
country: Russian Federation
facility: Alkermes Investigational Site
city: Tonnel'nyy
country: Russian Federation
facility: Alkermes Investigational Site
city: Belgrade
country: Serbia
facility: Alkermes Investigational Site
city: Belgrad
country: Serbia
facility: Alkermes Investigational Site
city: Kragujevac
country: Serbia
facility: Alkermes Investigational Site
city: Novi Kneževac
country: Serbia
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Kherson
country: Ukraine
facility: Alkermes Investigational Site
city: Kyiv
country: Ukraine
facility: Alkermes Investigational Site
city: Lviv
country: Ukraine
facility: Alkermes Investigational Site
city: Poltava
country: Ukraine
facility: Alkermes Investigational Site
city: Smila
country: Ukraine
facility: Alkermes Investigational Site
city: Vinnytsia
country: Ukraine
facility: Alkermes Investigational Site
city: Headington
country: United Kingdom
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References: