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SchizophreniaPhase 3NCT01626456

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

A Phase 3 study testing ALKS 9072, Low and ALKS 9072, High in people with Schizophrenia, run by Alkermes, Inc. at 82 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial 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. 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 and ALKS 9072, High
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
478 participants
Where
82 sitesin 8 countries
Study dates
Jun 2012to Apr 2015
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

  • (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
Show all 9Show fewer
  • 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

Who cannot join

  • (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
Show all 15Show fewer
  • (New Subjects)
  • History of poor or inadequate clinical response to treatment with aripiprazole
  • History of treatment resistance
  • Diagnosis of current substance dependence (including alcohol)
  • Pregnant, lactating, or breastfeeding
  • Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
  • Currently under involuntary hospitalization
  • Current or expected incarceration
  • Additional inclusion/exclusion criteria may apply

Trial locations and contacts

82 sites in 8 countries.

82 sites in 8 countries

United States25 sites

  • Alkermes Investigational Site

    Atlanta, Georgia, 30308

  • Alkermes Investigational Site

    Austin, Texas, 78731

  • Alkermes Investigational Site

    Austin, Texas, 78754

  • Alkermes Investigational Site

    Charleston, South Carolina, 29407

  • Alkermes Investigational Site

    Chicago, Illinois, 60611

  • Alkermes Investigational Site

    Chicago, Illinois, 60640

  • Alkermes Investigational Site

    Creve Coeur, Missouri, 63141

  • 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

    La Habra, California, 90631

  • 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

    Overland Park, Kansas, 66212

  • Alkermes Investigational Site

    Philadelphia, Pennsylvania, 19139

  • Alkermes Investigational Site

    Rockville, Maryland, 20850

  • Alkermes Investigational Site

    San Diego, California, 92123

  • Alkermes Investigational Site

    Springdale, Arkansas, 72764

  • Alkermes Investigational Site

    St Louis, Missouri, 63118

  • Alkermes Investigational Site

    Washington D.C., District of Columbia, 20016

Other trials in United States

Russia14 sites

  • Alkermes Investigational Site

    Khot'kovo

  • Alkermes Investigational Site

    Lipetsk

  • Alkermes Investigational Site

    Moscow

  • Alkermes Investigational Site

    Nikol’skoye, Gatchinckiy

  • Alkermes Investigational Site

    Nizhny Novgorod

  • Alkermes Investigational Site

    Rostov-on-Don

  • Alkermes Investigational Site

    Saint Petersburg

  • Alkermes Investigational Site

    Samara

  • Alkermes Investigational Site

    Saratov

  • Alkermes Investigational Site

    Staritsa, Orenburg Oblast

  • Alkermes Investigational Site

    Stavropol

  • Alkermes Investigational Site

    Talagi

  • Alkermes Investigational Site

    Voronezh

  • Alkermes Investigational Site

    Yaroslavl

Other trials in Russia

Bulgaria13 sites

  • Alkermes Investigational Site

    Burgas

  • Alkermes Investigational Site

    Kazanlak

  • Alkermes Investigational Site

    Novi Iskar

  • Alkermes Investigational Site

    Pazardzhik

  • Alkermes Investigational Site

    Pleven

  • Alkermes Investigational Site

    Plovdiv

  • Alkermes Investigational Site

    Radnevo

  • Alkermes Investigational Site

    Rousse

  • Alkermes Investigational Site

    Sofia

  • Alkermes Investigational Site

    Stara Zagora

  • Alkermes Investigational Site

    Targovishte

  • Alkermes Investigational Site

    Veliko Tarnovo

  • Alkermes Investigational Site

    Vratsa

Other trials in Bulgaria

Ukraine12 sites

  • Alkermes Investigational Site

    Chernihiv

  • Alkermes Investigational Site

    Donetsk

  • Alkermes Investigational Site

    Kharkiv

  • Alkermes Investigational Site

    Kyiv

  • Alkermes Investigational Site

    Luhansk

  • Alkermes Investigational Site

    Lviv

  • Alkermes Investigational Site

    Poltava

  • Alkermes Investigational Site

    Simferopol

  • Alkermes Investigational Site

    Stepanivka, Kherson Oblast

  • Alkermes Investigational Site

    Ternopil

  • Alkermes Investigational Site

    Uzhhorod

  • Alkermes Investigational Site

    Vinnytsia

Other trials in Ukraine

Philippines6 sites

  • Alkermes Investigational Site

    Cebu City

  • Alkermes Investigational Site

    Iloilo City

  • Alkermes Investigational Site

    Mandaluyong

  • Alkermes Investigational Site

    Manila

  • Alkermes Investigational Site

    Mariveles, Bataan

  • Alkermes Investigational Site

    Pasig

Other trials in Philippines

Romania5 sites

  • Alkermes Investigational Site

    Bucharest

  • Alkermes Investigational Site

    Craiova

  • Alkermes Investigational Site

    Iași

  • Alkermes Investigational Site

    Oradea

  • Alkermes Investigational Site

    Târgu Mureş, Mureș County

Other trials in Romania

Malaysia4 sites

  • Alkermes Investigational Site

    Cheras

  • Alkermes Investigational Site

    Johor Bahru

  • Alkermes Investigational Site

    Kuala Lumpur

  • Alkermes Investigational Site

    Kuching

Other trials in Malaysia

South Korea3 sites

  • Alkermes Investigational Site

    Jeju City

  • Alkermes Investigational Site

    Jeollanam-do

  • Alkermes Investigational Site

    Seoul

Other trials in South Korea

About this study

Official title: 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

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.

Conditions
Schizophrenia
Being tested
ALKS 9072, Low, ALKS 9072, High
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, LowDrug

    IM injection, given monthly

  • ALKS 9072, HighDrug

    IM injection, given monthly

Study groups in NCT01626456
Study groupRoleWhat they receive
ALKS 9072, LowExperimentalNot described
Receives: Drug: ALKS 9072, Low
ALKS 9072, HighExperimentalNot described
Receives: Drug: ALKS 9072, High

What is being measured

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

  1. Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

    This measure includes incidences >5%.

    Measured: 52 weeks

Secondary outcomes (5)

  1. Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)

    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.

    Measured: 52 weeks

  2. Discontinuation From Study Due to Adverse Events (AEs)

    Number of subjects who discontinued the study due to AE.

    Measured: 52 weeks

  3. Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.

    Measured: 52 weeks

  4. Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests

    Includes incidence >2% but <5%.

    Measured: 52 weeks

  5. Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores

    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), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).

    Measured: 52 weeks

Timeline

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

  1. First posted22 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626456
Sponsor's protocol ID
ALK9072-003EXT
Status last verified
Aug 2018
First submitted
15 Jun 2012
Last updated
25 Sep 2018
Data monitoring committee
No

Publications

  • Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.

    PubMed 28350572

  • 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

  • Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.

    PubMed 30109845

  • Weiden PJ, Du Y, Liu CC, Stanford AD. Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period. CNS Spectr. 2019 Aug;24(4):419-425. doi: 10.1017/S1092852918000986. Epub 2018 Jun 26.

    PubMed 29941057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 9072, Low and ALKS 9072, High in people with Schizophrenia, run by Alkermes, Inc. at 82 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 9 inclusion and 15 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Russia, Bulgaria, Ukraine, 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 27 Oct 2016). 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 of Subjects With Treatment-emergent Adverse Events (TEAEs) (time frame: 52 weeks). 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 NCT01626456, which also lists 5 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 Sep 2018.

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