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A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

NCT01626456•Alkermes, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(Subjects who participated in ALK9072-003)
•Completed the ALK9072-003 Day 85 visit
•Continues to require treatment with an antipsychotic medication
•(New Subjects)
•On a stable dose of oral antipsychotic medication
•Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
•Has been able to achieve outpatient status for more than 3 months prior to screening
•Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
•Resides in a stable living situation

Exclusion Criteria

•(Subjects who participated in ALK9072-003)
•Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
•Missed more than 1 scheduled study visit during participation in study ALK9072-003
•Has a significant or unstable medical condition that would preclude safe completion of the current study
•Subject is pregnant or breastfeeding
•Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
•(New Subjects)
•History of poor or inadequate clinical response to treatment with aripiprazole
•History of treatment resistance
•Diagnosis of current substance dependence (including alcohol)
+4 more criteria

Locations (82)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Springdale, Arkansas, United States

Alkermes Investigational Site

Garden Grove, California, United States

Alkermes Investigational Site

La Habra, California, United States

Alkermes Investigational Site

Oakland, California, United States

Alkermes Investigational Site

Oceanside, California, United States

Alkermes Investigational Site

San Diego, California, United States

Alkermes Investigational Site

Washington D.C., District of Columbia, United States

Alkermes Investigational Site

Fort Lauderdale, Florida, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

September 25, 2018

Enrollment

478

ACTUAL participants

Conditions

Schizophrenia

Interventions

ALKS 9072, Low

DRUG

ALKS 9072, High

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia