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NCT03201757 Clinical Trial

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03201757
Other study ID # ALK3831-A308
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 15, 2017
Est. completion date September 6, 2023

Study information
Verified date February 2024
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 524
Est. completion date September 6, 2023
Est. primary completion date September 6, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ALKS 3831
Olanzapine + samidorphan, daily oral dosing

Locations
Country Name City State
Austria Alkermes Investigational Site Vienna
Bulgaria Alkermes Investigational Site Burgas
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
Ireland Alkermes Investigational Site Galway
Israel Alkermes Investigational Site Jerusalem
Israel Alkermes Investigational Site Ramat Gan
Italy Alkermes Investigational Site Brescia
Italy Alkermes Investigational Site Napoli
Korea, Republic of Alkermes Investigational Site Busan
Poland Alkermes Investigational Site Poznan
Puerto Rico Alkermes Investigational Site San Juan
Russian Federation Alkermes Investigational Site Arkhangel'sk
Russian Federation Alkermes Investigational Site Moscow
Russian Federation Alkermes Investigational Site Roshchino
Russian Federation Alkermes Investigational Site Rostov-on-Don
Russian Federation Alkermes Investigational Site Saint Petersburg
Russian Federation Alkermes Investigational Site Samara
Russian Federation Alkermes Investigational Site Saratow
Russian Federation Alkermes Investigational Site Tonnel'nyy
Serbia Alkermes Investigational Site Belgrad
Serbia Alkermes Investigational Site Belgrade
Serbia Alkermes Investigational Site Kragujevac
Serbia Alkermes Investigational Site Novi Kneževac
Ukraine Alkermes Investigational Site Kharkiv
Ukraine Alkermes Investigational Site Kherson
Ukraine Alkermes Investigational Site Kyiv
Ukraine Alkermes Investigational Site Lviv
Ukraine Alkermes Investigational Site Poltava
Ukraine Alkermes Investigational Site Smila
Ukraine Alkermes Investigational Site Vinnytsia
United Kingdom Alkermes Investigational Site Headington
United States Alkermes Investigational Site Anaheim California
United States Alkermes Investigational Site Atlanta Georgia
United States Alkermes Investigational Site Atlanta Georgia
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 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 Chicago Illinois
United States Alkermes Investigational Site Cincinnati Ohio
United States Alkermes Investigational Site Culver City California
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 Eugene Oregon
United States Alkermes Investigational Site Flowood Mississippi
United States Alkermes Investigational Site Fort Worth Texas
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 Houston Texas
United States Alkermes Investigational Site Kansas City Missouri
United States Alkermes Investigational Site Las Vegas Nevada
United States Alkermes Investigational Site Lauderhill Florida
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 Palo Alto California
United States Alkermes Investigational Site Pico Rivera California
United States Alkermes Investigational Site Redlands California
United States Alkermes Investigational Site Richardson Texas
United States Alkermes Investigational Site Rochester New York
United States Alkermes Investigational Site Rogers Arkansas
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site San Diego California
United States Alkermes Investigational Site Temecula California
United States Alkermes Investigational Site Torrance California
United States Alkermes Investigational Site Winfield Illinois

Sponsors (1)
Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Ireland,  Israel,  Italy,  Korea, Republic of,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Change from baseline in body weight Up to 48 months
Other Change from baseline in Clinical Global Impression-Severity (CGI-S) scale Up to 48 months
Primary Safety will be measured by frequency of serious and non-serious adverse events Up to 48 months
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