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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

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: NCT03201757
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2017
Last Update Posted : July 12, 2021
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorder Bipolar I Disorder Drug: ALKS 3831 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ALKS 3831
Coated bilayer tablet
Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

Primary Outcome Measures :
  1. Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: Up to 48 months ]

Other Outcome Measures:
  1. Change from baseline in body weight [ Time Frame: Up to 48 months ]
  2. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: Up to 48 months ]

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:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Willing and able to give informed consent/assent as per local requirements
  • Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
  • Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
  • Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
  • Additional criteria may apply

Exclusion Criteria:

  • Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
  • Has a positive drug screen for drugs of abuse at study entry
  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
  • 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): NCT03201757

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Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Alkermes Medical Director Alkermes, Inc.
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Responsible Party: Alkermes, Inc. Identifier: NCT03201757    
Other Study ID Numbers: ALK3831-A308
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
ALKS 3831
Bipolar I
Additional relevant MeSH terms:
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Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders