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Trial record 1 of 10 for:    ALKS 3831
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A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

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
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
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 related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ALKS 3831
Oral tablet, daily dosing
Drug: ALKS 3831
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan




Primary Outcome Measures :
  1. Long-term safety and tolerability of ALKS 3831 assessed by the incidence of adverse events (AEs) [ Time Frame: Up to 56 weeks ]


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.


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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
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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
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Principal Investigator: Alkermes Medical Director Alkermes, Inc.

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02873208    
Other Study ID Numbers: ALK3831-A304
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alkermes, Inc.:
Alkermes
ALKS 3831
Samidorphan
Schizophrenia
Safety
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders