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

September 20, 2024 updated by: Alkermes, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
523

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Alkermes Investigational Site
  • Bulgaria
      • Burgas, 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
        • Alkermes Investigational Site
  • Ireland
      • Galway, Ireland
        • Alkermes Investigational Site
  • Israel
      • Jerusalem, Israel
        • Alkermes Investigational Site
      • Ramat Gan, Israel
        • Alkermes Investigational Site
  • Italy
      • Brescia, Italy
        • Alkermes Investigational Site
      • Napoli, Italy
        • Alkermes Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Alkermes Investigational Site
  • Poland
      • Poznań, Poland
        • Alkermes Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico
        • Alkermes Investigational Site
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Alkermes Investigational Site
      • Moscow, Russian Federation
        • Alkermes Investigational Site
      • Roshchino, Russian Federation
        • Alkermes Investigational Site
      • Rostov-on-Don, Russian Federation
        • Alkermes Investigational Site
      • Saint Petersburg, Russian Federation
        • Alkermes Investigational Site
      • Samara, Russian Federation
        • Alkermes Investigational Site
      • Saratow, Russian Federation
        • Alkermes Investigational Site
      • Tonnel'nyy, Russian Federation
        • Alkermes Investigational Site
  • Serbia
      • Belgrad, Serbia
        • Alkermes Investigational Site
      • Belgrade, Serbia
        • Alkermes Investigational Site
      • Kragujevac, Serbia
        • Alkermes Investigational Site
      • Novi Kneževac, Serbia
        • Alkermes Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • Alkermes Investigational Site
      • Kherson, Ukraine
        • Alkermes Investigational Site
      • Kyiv, Ukraine
        • Alkermes Investigational Site
      • Lviv, Ukraine
        • Alkermes Investigational Site
      • Poltava, Ukraine
        • Alkermes Investigational Site
      • Smila, Ukraine
        • Alkermes Investigational Site
      • Vinnytsia, Ukraine
        • Alkermes Investigational Site
  • United Kingdom
      • Headington, United Kingdom
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Alkermes Investigational Site
    • California
      • 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
      • Long Beach, California, United States, 90822
        • Alkermes Investigational Site
      • Oakland, California, United States, 94607
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92056
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Palo Alto, California, United States, 94305
        • 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, 92013
        • Alkermes Investigational Site
      • Temecula, California, United States, 92591
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • Alkermes Investigational Site
    • Florida
      • Lauderhill, Florida, United States, 33319
        • Alkermes Investigational Site
      • North Miami, Florida, United States, 33161
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30331
        • Alkermes Investigational Site
      • Augusta, Georgia, United States, 30912
        • Alkermes Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Chicago, Illinois, United States, 60611
        • Alkermes Investigational Site
      • Winfield, Illinois, United States, 60190
        • Alkermes Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63118
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Alkermes Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Alkermes Investigational Site
      • Marlton, New Jersey, United States, 08053
        • Alkermes Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Alkermes Investigational Site
      • Rochester, New York, United States, 14615
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • Alkermes Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77030
        • Alkermes Investigational Site
      • Richardson, Texas, United States, 75080
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALKS 3831
Coated bilayer tablet
Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Up to 48 months
Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Time Frame: Up to 48 months
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
Up to 48 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in body weight
Time Frame: Up to 48 months
Up to 48 months
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alkermes, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alkermes Medical Director, Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALK3831-A308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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