A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02873208 |
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Recruitment Status :
Completed
First Posted : August 19, 2016
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
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Sponsor:
Alkermes, Inc.
Information provided by (Responsible Party):
Alkermes, Inc.
- Study Details
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Brief Summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: ALKS 3831 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 266 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia |
| Actual Study Start Date : | August 7, 2016 |
| Actual Primary Completion Date : | October 17, 2019 |
| Actual Study Completion Date : | October 17, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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Experimental: ALKS 3831
Oral tablet, daily dosing
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Drug: ALKS 3831
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan |
Primary Outcome Measures :
- Number of Subjects With Adverse Events [ Time Frame: Up to 52 weeks ]Overall summary of treatment emergent adverse events during the treatment period
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873208
Locations
| United States, Arkansas | |
| Alkermes Investigational Site | |
| Little Rock, Arkansas, United States, 72211 | |
| Alkermes Investigational Site | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Alkermes Investigational Site | |
| Anaheim, California, United States, 92805 | |
| Alkermes Investigational Site | |
| Cerritos, California, United States, 90703 | |
| Alkermes Investigational Site | |
| Culver City, California, United States, 90230 | |
| Alkermes Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| Alkermes Investigational Site | |
| Glendale, California, United States, 91206 | |
| Alkermes Investigational Site | |
| Lemon Grove, California, United States, 91945 | |
| Alkermes Investigational Site | |
| Long Beach, California, United States, 90822 | |
| Alkermes Investigational Site | |
| Oakland, California, United States, 94612 | |
| Alkermes Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Alkermes Investigational Site | |
| Orange, California, United States, 92868 | |
| Alkermes Investigational Site | |
| Pico Rivera, California, United States, 90660 | |
| Alkermes Investigational Site | |
| Redlands, California, United States, 92374 | |
| Alkermes Investigational Site | |
| San Diego, California, United States, 92103 | |
| Alkermes Investigational Site | |
| San Diego, California, United States, 92123 | |
| Alkermes Investigational Site | |
| Temecula, California, United States, 92591 | |
| Alkermes Investigational Site | |
| Torrance, California, United States, 90502 | |
| United States, Florida | |
| Alkermes Investigational Site | |
| Hollywood, Florida, United States, 33024 | |
| Alkermes Investigational Site | |
| Lauderhill, Florida, United States, 33319 | |
| Alkermes Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Alkermes Investigational Site | |
| Atlanta, Georgia, United States, 30329 | |
| Alkermes Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| Alkermes Investigational Site | |
| Decatur, Georgia, United States, 30030 | |
| United States, Illinois | |
| Alkermes Investigational Site | |
| Chicago, Illinois, United States, 60640 | |
| United States, Michigan | |
| Alkermes Investigational Site | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Mississippi | |
| Alkermes Investigational Site | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Alkermes Investigational Site | |
| Creve Coeur, Missouri, United States, 63141 | |
| Alkermes Investigational Site | |
| Saint Louis, Missouri, United States, 63128 | |
| United States, Nevada | |
| Alkermes Investigational Site | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Alkermes Investigational Site | |
| Berlin, New Jersey, United States, 08009 | |
| Alkermes Investigational Site | |
| Marlton, New Jersey, United States, 08053 | |
| United States, New York | |
| Alkermes Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| Alkermes Investigational Site | |
| Jamaica, New York, United States, 11432 | |
| Alkermes Investigational Site | |
| Rochester, New York, United States, 14615 | |
| United States, Ohio | |
| Alkermes Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| Alkermes Investigational Site | |
| Dayton, Ohio, United States, 45417 | |
| United States, Texas | |
| Alkermes Investigational Site | |
| Austin, Texas, United States, 78754 | |
| Alkermes Investigational Site | |
| Austin, Texas, United States, 78759 | |
| Alkermes Investigational Site | |
| Dallas, Texas, United States, 75243 | |
| Alkermes Investigational Site | |
| DeSoto, Texas, United States, 75115 | |
| Alkermes Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Alkermes Investigational Site | |
| Bellevue, Washington, United States, 98007 | |
| Puerto Rico | |
| Alkermes Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Alkermes Investigational Site | |
| San Juan, Puerto Rico, 00926 | |
Sponsors and Collaborators
Alkermes, Inc.
Investigators
| Principal Investigator: | Alkermes Medical Director | Alkermes, Inc. |
Study Documents (Full-Text)
Documents provided by Alkermes, Inc.:
Documents provided by Alkermes, Inc.:
Study Protocol [PDF] April 26, 2018
Statistical Analysis Plan [PDF] June 11, 2019
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT02873208 |
| Other Study ID Numbers: |
ALK3831-A304 |
| First Posted: | August 19, 2016 Key Record Dates |
| Results First Posted: | July 21, 2021 |
| Last Update Posted: | July 21, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Alkermes, Inc.:
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Alkermes ALKS 3831 Samidorphan Schizophrenia Safety |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |