MedDataX Logo

An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

NCT ID: NCT01895452

Last Updated: 2017-08-25

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

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-06-30

Brief Summary

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

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Related Clinical Trials

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

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

NCT01626456

Schizophrenia
COMPLETED PHASE3

A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

NCT01493726

Schizophrenia
COMPLETED PHASE1

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

NCT02873208

Schizophrenia
COMPLETED PHASE3

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

NCT02669758

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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

ALKS 9072, Low Dose

Group Type EXPERIMENTAL

ALKS 9072, Low Dose

Intervention Type DRUG

Intramuscular injection, given monthly

ALKS 9072, High Dose

Group Type EXPERIMENTAL

ALKS 9072, High Dose

Intervention Type DRUG

Intramuscular injection, given monthly

Interventions

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

ALKS 9072, Low Dose

Intramuscular injection, given monthly

Intervention Type DRUG

ALKS 9072, High Dose

Intramuscular injection, given monthly

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Completed the treatment period of Study ALK9072-003EXT
* Continues to require chronic treatment with an antipsychotic medication
* Continues to reside in a stable living situation
* Continues to have an identified reliable informant

Exclusion Criteria

* Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
* 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, or has pending legal action which may impact compliance with study participation or procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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.

Robert Risinger, MD

Role: STUDY_DIRECTOR

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

Little Rock, Arkansas, United States

Site Status

Alkermes Investigational Site

Garden Grove, 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

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

Site Status

Alkermes Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Alkermes Investigational Site

Leesburg, Florida, United States

Site Status

Alkermes Investigational Site

Atlanta, Georgia, United States

Site Status

Alkermes Investigational Site

Chicago, Illinois, United States

Site Status

Alkermes Investigational Site

Chicago, Illinois, United States

Site Status

Alkermes Investigational Site

Hoffman Estates, Illinois, United States

Site Status

Alkermes Investigational Site

Shreveport, Louisiana, United States

Site Status

Alkermes Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Alkermes Investigational Site

Dallas, Texas, United States

Site Status

Alkermes Investigational Site

Dallas, Texas, United States

Site Status

Alkermes Investigational Site

Burgas, , Bulgaria

Site Status

Alkermes Investigational Site

Novi Iskar, , Bulgaria

Site Status

Alkermes Investigational Site

Pazardzhik, , Bulgaria

Site Status

Alkermes Investigational Site

Plovdiv, , Bulgaria

Site Status

Alkermes Investigational Site

Sofia, , Bulgaria

Site Status

Alkermes Investigational Site

Targovishte, , Bulgaria

Site Status

Alkermes Investigational Site

Veliko Tarnovo, , Bulgaria

Site Status

Alkermes Investigational Site

Vratsa, , Bulgaria

Site Status

Alkermes Investigational Site

Cheras, , Malaysia

Site Status

Alkermes Investigational Site

Johor Bahru, , Malaysia

Site Status

Alkermes Investigational Site

Kuala Lampur, , Malaysia

Site Status

Alkermes Investigational Site

Kuching, , Malaysia

Site Status

Alkermes Investigational Site

Mariveles, Bataan, Philippines

Site Status

Alkermes Investigational Site

Cebu City, , Philippines

Site Status

Alkermes Investigational Site

Iloilo City, , Philippines

Site Status

Alkermes Investigational Site

Mandaluyong, , Philippines

Site Status

Alkermes Investigational Site

Manila, , Philippines

Site Status

Alkermes Investigational Site

Bucharest, , Romania

Site Status

Alkermes Investigational Site

Oradea, , Romania

Site Status

Alkermes Investigational Site

Târgu Mureş, , Romania

Site Status

Alkermes Investigational Site

Roshchino, Vyborgskiy, Russia

Site Status

Alkermes Investigational Site

Lipetsk, , Russia

Site Status

Alkermes Investigational Site

Moscow, , Russia

Site Status

Alkermes Investigational Site

Rostov-on-Don, , Russia

Site Status

Alkermes Investigational Site

Saint Petersburg, , Russia

Site Status

Roshchino township

Samara, , Russia

Site Status

Roshchino township

Saratov, , Russia

Site Status

Alkermes Investigational Site

Stavropol, , Russia

Site Status

Alkermes Investigational Site

Talagi, , Russia

Site Status

Alkermes Investigational Site

Yaroslavl, , Russia

Site Status

Alkermes Investigational Site

Jeollanam-do, , South Korea

Site Status

Alkermes Investigational Site

Chernihiv, , Ukraine

Site Status

Alkermes Investigational Site

Donetsk, , Ukraine

Site Status

Alkermes Investigational Site

Kharkiv, , Ukraine

Site Status

Alkermes Investigational Site

Kherson, , Ukraine

Site Status

Alkermes Investigational Site

Kyiv, , Ukraine

Site Status

Alkermes Investigational Site

Lviv, , Ukraine

Site Status

Alkermes Investigational Site

Poltava, , Ukraine

Site Status

Alkermes Investigational Site

Ternopil, , Ukraine

Site Status

Roshchino township

Vinnytsia, , Ukraine

Site Status

Countries

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

United States Bulgaria Malaysia Philippines Romania Russia South Korea Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.

Reference Type DERIVED
PMID: 33761928 (View on PubMed)

Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.

Reference Type DERIVED
PMID: 32841554 (View on PubMed)

Other Identifiers

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

ALK9072-003EXT2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
NCT00722176 COMPLETED PHASE2
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
NCT02161718 COMPLETED PHASE2
Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
NCT02892422 COMPLETED PHASE3
Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
NCT00463372 COMPLETED PHASE1
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
NCT01708616 COMPLETED PHASE1
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
NCT01499563 COMPLETED PHASE2
A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.
NCT00558298 COMPLETED PHASE3
Safety and Efficacy of Seroquel in First Episode Schizophrenia
NCT00254241 COMPLETED PHASE4
Risk of Breakthrough Symptoms With Long-Acting Injectable Medications
NCT05473741 RECRUITING
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT02109562 COMPLETED PHASE3
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
NCT01009047 COMPLETED PHASE3
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
NCT00921804 COMPLETED PHASE2
An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
NCT01939548 TERMINATED PHASE2
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
NCT00922272 COMPLETED PHASE2
A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia.
NCT00034775 COMPLETED PHASE3
A Long-term Safety Study for Long-acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.
NCT00495118 COMPLETED PHASE3
A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules
NCT04567524 COMPLETED PHASE2
A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone
NCT02019329 COMPLETED PHASE1
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
NCT00272584 COMPLETED PHASE4
An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders
NCT01855074 COMPLETED PHASE4
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia
NCT01559272 COMPLETED PHASE1
A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)
NCT01235520 COMPLETED PHASE3
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
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
NCT01683058 COMPLETED PHASE3
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
NCT05321602 COMPLETED PHASE1