Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
NCT ID: NCT03201757
Last Updated: 2024-09-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
523 participants
INTERVENTIONAL
2017-06-15
2023-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALKS 3831
Coated bilayer tablet
ALKS 3831
Olanzapine + samidorphan, daily oral dosing
Interventions
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ALKS 3831
Olanzapine + samidorphan, daily oral dosing
Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
70 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alkermes Medical Director
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Rogers, Arkansas, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Cerritos, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Glendale, California, United States
Alkermes Investigational Site
Long Beach, California, 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
San Diego, California, United States
Alkermes Investigational Site
Temecula, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
North Miami, Florida, 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
Decatur, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Winfield, Illinois, United States
Alkermes Investigational Site
Grand Rapids, Michigan, United States
Alkermes Investigational Site
Flowood, Mississippi, United States
Alkermes Investigational Site
Kansas City, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Las Vegas, Nevada, United States
Alkermes Investigational Site
Berlin, New Jersey, United States
Alkermes Investigational Site
Marlton, New Jersey, United States
Alkermes Investigational Site
Brooklyn, New York, United States
Alkermes Investigational Site
Rochester, New York, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Eugene, Oregon, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Alkermes Investigational Site
Fort Worth, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
Richardson, Texas, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Alkermes Investigational Site
Vienna, , Austria
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, , Bulgaria
Alkermes Investigational Site
Galway, , Ireland
Alkermes Investigational Site
Jerusalem, , Israel
Alkermes Investigational Site
Ramat Gan, , Israel
Alkermes Investigational Site
Brescia, , Italy
Alkermes Investigational Site
Napoli, , Italy
Alkermes Investigational Site
Poznan, , Poland
Alkermes Investigational Site
San Juan, , Puerto Rico
Alkermes Investigational Site
Arkhangelsk, , Russia
Alkermes Investigational Site
Moscow, , Russia
Alkermes Investigational Site
Roshchino, , Russia
Alkermes Investigational Site
Rostov-on-Don, , Russia
Alkermes Investigational Site
Saint Petersburg, , Russia
Alkermes Investigational Site
Samara, , Russia
Alkermes Investigational Site
Saratov, , Russia
Alkermes Investigational Site
Tonnel'nyy, , Russia
Alkermes Investigational Site
Belgrade, , Serbia
Alkermes Investigational Site
Kragujevac, , Serbia
Alkermes Investigational Site
Novi Kneževac, , Serbia
Alkermes Investigational Site
Busan, , South Korea
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, , Ukraine
Alkermes Investigational Site
Headington, , United Kingdom
Countries
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References
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Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK3831-A308
Identifier Type: -
Identifier Source: org_study_id
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