SchizophreniaPhase 3NCT01895452

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

A Phase 3 study testing ALKS 9072, Low Dose and ALKS 9072, High Dose in people with Schizophrenia, run by Alkermes, Inc. at 57 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia
What is being tested?: ALKS 9072, Low Dose and ALKS 9072, High Dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 291 participants
Where: 57 sitesin 8 countries
Study dates: Jul 2013to Jun 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

57 sites in 8 countries.

Country

City, postcode or hospital

57 sites in 8 countries

United States17 sites

Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Chicago, Illinois, 60611
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Dallas, Texas, 75231
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Fort Lauderdale, Florida, 33308
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Leesburg, Florida, 34748
Alkermes Investigational Site
Little Rock, Arkansas, 72201
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73116
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Shreveport, Louisiana, 71101
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016

Other trials in United States

Russia10 sites

Alkermes Investigational Site
Lipetsk
Alkermes Investigational Site
Moscow
Alkermes Investigational Site
Roshchino, Vyborgskiy
Alkermes Investigational Site
Rostov-on-Don
Alkermes Investigational Site
Saint Petersburg
Roshchino township
Samara
Roshchino township
Saratov
Alkermes Investigational Site
Stavropol
Alkermes Investigational Site
Talagi
Alkermes Investigational Site
Yaroslavl

Other trials in Russia

Ukraine9 sites

Alkermes Investigational Site
Chernihiv
Alkermes Investigational Site
Donetsk
Alkermes Investigational Site
Kharkiv
Alkermes Investigational Site
Kherson
Alkermes Investigational Site
Kyiv
Alkermes Investigational Site
Lviv
Alkermes Investigational Site
Poltava
Alkermes Investigational Site
Ternopil
Roshchino township
Vinnytsia, 61068

Other trials in Ukraine

Bulgaria8 sites

Alkermes Investigational Site
Burgas
Alkermes Investigational Site
Novi Iskar
Alkermes Investigational Site
Pazardzhik
Alkermes Investigational Site
Plovdiv
Alkermes Investigational Site
Sofia
Alkermes Investigational Site
Targovishte
Alkermes Investigational Site
Veliko Tarnovo
Alkermes Investigational Site
Vratsa

Other trials in Bulgaria

Philippines5 sites

Alkermes Investigational Site
Cebu City
Alkermes Investigational Site
Iloilo City
Alkermes Investigational Site
Mandaluyong
Alkermes Investigational Site
Manila
Alkermes Investigational Site
Mariveles, Bataan

Other trials in Philippines

Malaysia4 sites

Alkermes Investigational Site
Cheras
Alkermes Investigational Site
Johor Bahru
Alkermes Investigational Site
Kuala Lampur
Alkermes Investigational Site
Kuching

Other trials in Malaysia

Romania3 sites

Alkermes Investigational Site
Bucharest
Alkermes Investigational Site
Oradea
Alkermes Investigational Site
Târgu Mureş

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South Korea1 site

Alkermes Investigational Site
Jeollanam-do

Other trials in South Korea

About this study

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

Conditions: Schizophrenia
Being tested: ALKS 9072, Low Dose, ALKS 9072, High Dose
Keywords: Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALKS 9072, Low DoseDrug
Intramuscular injection, given monthly
ALKS 9072, High DoseDrug
Intramuscular injection, given monthly

Study groups in NCT01895452
Study group	Role	What they receive
ALKS 9072, Low Dose	Experimental	Not described Receives: Drug: ALKS 9072, Low Dose
ALKS 9072, High Dose	Experimental	Not described Receives: Drug: ALKS 9072, High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
This measure includes all incidences, including those that occurred >5%.
Measured: Up to 12 months

Secondary outcomes (2)

Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Measured: Up to 12 months
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jun 2016

First posted10 Jul 2013 (estimated)
Study startJul 2013
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01895452
Sponsor's protocol ID: ALK9072-003EXT2
Status last verified: Jul 2017
First submitted: 5 Jul 2013
Last updated: 25 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33761928
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.
PubMed 32841554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
ClinicalTrials.gov ID: NCT01895452
Acronym / sponsor ID: ALK9072-003EXT2
Conditions: Schizophrenia
Keywords: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 291 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Jul 2013 (estimated)
Results: Posted 25 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ALKS 9072, Low Dose	Experimental	Drug: ALKS 9072, Low Dose
ALKS 9072, High Dose	Experimental	Drug: ALKS 9072, High Dose

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 9072, Low DoseIntramuscular injection, given monthly	Drug	ALKS 9072, Low Dose
ALKS 9072, High DoseIntramuscular injection, given monthly	Drug	ALKS 9072, High Dose

Primary outcome

Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
This measure includes all incidences, including those that occurred >5%.

2 secondary outcomes

Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
Time frame: Up to 12 months
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 25 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALKS 9072, Low	65	61
ALKS 9072, High	226	198

Primary outcome: Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	ALKS 9072, Low n = 65	ALKS 9072, High n = 226
Value	21	94

Population analysed: Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at every study visit for up to 35 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALKS 9072, Low	0 of 65 (0%)	11 of 65 (16.9%)	0 of 65
ALKS 9072, High	4 of 226 (1.8%)	26 of 226 (11.5%)	0 of 226

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33761928McEvoy 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.
Derived from this study: PubMed 32841554Lauriello 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.

Related trials for Schizophrenia

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Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Risinger, MD study director

Alkermes, Inc.

57 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 9072, Low Dose and ALKS 9072, High Dose in people with Schizophrenia, run by Alkermes, Inc. at 57 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Russia, Ukraine, Bulgaria, Philippines and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01895452, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.