MedDataX Logo

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

NCT ID: NCT02873208

Last Updated: 2021-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-07

Study Completion Date

2019-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02669758

Schizophrenia
COMPLETED PHASE3

A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

NCT02161718

Schizophrenia Alcohol Use Disorder
COMPLETED PHASE2

A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

NCT01469039

Schizophrenia
COMPLETED PHASE3

A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

NCT01493726

Schizophrenia
COMPLETED PHASE1

A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT01626456

Schizophrenia
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALKS 3831

Oral tablet, daily dosing

Group Type EXPERIMENTAL

ALKS 3831

Intervention Type DRUG

Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALKS 3831

Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alkermes Medical Director

Role: PRINCIPAL_INVESTIGATOR

Alkermes, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alkermes Investigational Site

Little Rock, Arkansas, United States

Site Status

Alkermes Investigational Site

Springdale, Arkansas, United States

Site Status

Alkermes Investigational Site

Anaheim, California, United States

Site Status

Alkermes Investigational Site

Cerritos, California, United States

Site Status

Alkermes Investigational Site

Culver City, California, United States

Site Status

Alkermes Investigational Site

Garden Grove, California, United States

Site Status

Alkermes Investigational Site

Glendale, California, United States

Site Status

Alkermes Investigational Site

Lemon Grove, California, United States

Site Status

Alkermes Investigational Site

Long Beach, California, United States

Site Status

Alkermes Investigational Site

Oakland, California, United States

Site Status

Alkermes Investigational Site

Oceanside, California, United States

Site Status

Alkermes Investigational Site

Orange, California, United States

Site Status

Alkermes Investigational Site

Pico Rivera, California, United States

Site Status

Alkermes Investigational Site

Redlands, California, United States

Site Status

Alkermes Investigational Site

San Diego, California, United States

Site Status

Alkermes Investigational Site

San Diego, California, United States

Site Status

Alkermes Investigational Site

Temecula, California, United States

Site Status

Alkermes Investigational Site

Torrance, California, United States

Site Status

Alkermes Investigational Site

Hollywood, Florida, United States

Site Status

Alkermes Investigational Site

Lauderhill, Florida, United States

Site Status

Alkermes Investigational Site

North Miami, Florida, United States

Site Status

Alkermes Investigational Site

Atlanta, Georgia, United States

Site Status

Alkermes Investigational Site

Augusta, Georgia, United States

Site Status

Alkermes Investigational Site

Decatur, Georgia, United States

Site Status

Alkermes Investigational Site

Chicago, Illinois, United States

Site Status

Alkermes Investigational Site

Grand Rapids, Michigan, United States

Site Status

Alkermes Investigational Site

Flowood, Mississippi, United States

Site Status

Alkermes Investigational Site

Creve Coeur, Missouri, United States

Site Status

Alkermes Investigational Site

St Louis, Missouri, United States

Site Status

Alkermes Investigational Site

Las Vegas, Nevada, United States

Site Status

Alkermes Investigational Site

Berlin, New Jersey, United States

Site Status

Alkermes Investigational Site

Marlton, New Jersey, United States

Site Status

Alkermes Investigational Site

Brooklyn, New York, United States

Site Status

Alkermes Investigational Site

Jamaica, New York, United States

Site Status

Alkermes Investigational Site

Rochester, New York, United States

Site Status

Alkermes Investigational Site

Canton, Ohio, United States

Site Status

Alkermes Investigational Site

Dayton, Ohio, United States

Site Status

Alkermes Investigational Site

Austin, Texas, United States

Site Status

Alkermes Investigational Site

Austin, Texas, United States

Site Status

Alkermes Investigational Site

Dallas, Texas, United States

Site Status

Alkermes Investigational Site

DeSoto, Texas, United States

Site Status

Alkermes Investigational Site

Houston, Texas, United States

Site Status

Alkermes Investigational Site

Bellevue, Washington, United States

Site Status

Alkermes Investigational Site

San Juan, , Puerto Rico

Site Status

Alkermes Investigational Site

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALK3831-A304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT01895452 COMPLETED PHASE3
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
NCT01683058 COMPLETED PHASE3
Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
NCT02360319 COMPLETED PHASE4
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
NCT03839251 COMPLETED PHASE4
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
NCT00705783 COMPLETED PHASE3
Safety and Efficacy of Seroquel in First Episode Schizophrenia
NCT00254241 COMPLETED PHASE4
An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)
NCT03055338 COMPLETED PHASE2
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
NCT03150771 COMPLETED PHASE1
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
NCT07061288 RECRUITING PHASE1
Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia
NCT03172871 COMPLETED PHASE3
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
NCT00088621 COMPLETED PHASE2
A Switch Study of BMS-337039 in Schizophrenic Out-patients
NCT00232687 COMPLETED PHASE4
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
NCT00563017 UNKNOWN NA
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
NCT00237939 COMPLETED PHASE3
Amisulpride in Schizophrenic Patients
NCT00331981 COMPLETED PHASE4
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
NCT05321602 COMPLETED PHASE1
Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
NCT03289026 COMPLETED PHASE4
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
NCT02634320 COMPLETED PHASE4
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
NCT02137993 COMPLETED PHASE4
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
NCT05962216 RECRUITING
Brexpiprazole in Patients With Acute Schizophrenia
NCT01810380 COMPLETED PHASE3
A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.
NCT00558298 COMPLETED PHASE3
A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
NCT01685931 COMPLETED PHASE4
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
NCT03198078 COMPLETED PHASE3
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders
NCT00036127 COMPLETED PHASE2/PHASE3