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Trial record 3 of 10 for:    ALKS 3831

A 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: NCT02669758
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : July 9, 2019
Last Update Posted : July 26, 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 : 281 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 : January 20, 2016
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ALKS 3831
Olanzapine + samidorphan; administered as a coated bilayer tablet.
Drug: ALKS 3831
Tablets were administered for daily dosing




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 52 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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
  • Agrees to use an acceptable method of contraception for the duration of the study.
  • Additional criteria may apply.

Exclusion Criteria:

  • Subject is currently taking medications that are contraindicated with olanzapine use.
  • 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): NCT02669758


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
Culver City, California, United States, 90230
Alkermes Investigational Site
Garden Grove, California, United States, 92845
Alkermes Investigational Site
Lemon Grove, California, United States, 91945
Alkermes Investigational Site
Orange, California, United States, 92868
Alkermes Investigational Site
San Diego, California, United States, 92103
United States, Florida
Alkermes Investigational Site
Miami, Florida, United States, 33161
United States, Illinois
Alkermes Investigational Site
Chicago, Illinois, United States, 60640
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nevada
Alkermes Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Alkermes Investigational Site
Marlton, New Jersey, United States, 08053
United States, Ohio
Alkermes Investigational Site
Dayton, Ohio, United States, 45417
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75243
Bulgaria
Alkermes Investigational Site
Burgas, Bulgaria
Alkermes Investigational Site
Kazanlak, 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
Serbia
Alkermes Investigational Site
Belgrade, Serbia
Alkermes Investigational Site
Kragujevac, Serbia
Alkermes Investigational Site
Novi Knezevac, Serbia
Ukraine
Alkermes Investigational Site
Kharkiv, Ukraine
Alkermes Investigational Site
Kiev, Ukraine
Alkermes Investigational Site
L'viv, Ukraine
Alkermes Investigational Site
Stepanovka, Ukraine
Alkermes Investigational Site
Vinnytsia, Ukraine
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Alkermes Medical Director Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] April 25, 2017
Statistical Analysis Plan  [PDF] October 5, 2017


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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02669758    
Other Study ID Numbers: ALK3831-A306
First Posted: February 1, 2016    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 26, 2019
Last Verified: July 2019
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