Working… Menu
Trial record 1 of 10 for:    ALKS 3831
Previous Study | Return to List | Next Study

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. Identifier: NCT02873208
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : October 30, 2019
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

Layout table for study information
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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT02873208

  Show 45 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Layout table for investigator information
Principal Investigator: Alkermes Medical Director Alkermes, Inc.

Layout table for additonal information
Responsible Party: Alkermes, Inc. 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.:
ALKS 3831
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders