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A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

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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

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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


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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     History of Changes
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