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    Summary
    EudraCT Number:2012-003996-20
    Sponsor's Protocol Code Number:ALK9072-003EXT
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-003996-20
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess how safe ALKS 9072 is when given for a long time period and how long its effects continue when used for the treatment of schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberALK9072-003EXT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01626456
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlkermes, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlkermes, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlkermes, Inc
    B.5.2Functional name of contact pointClinical Developement
    B.5.3 Address:
    B.5.3.1Street Address852 Winter Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 781-609 6542
    B.5.5Fax number+1 781-609 6542
    B.5.6E-mailLisa.Corey@alkermes.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code ALKS 9072
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaripiprazole lauroxil
    D.3.9.1CAS number 1259305-29-7
    D.3.9.2Current sponsor codeALKS 9072
    D.3.9.3Other descriptive nameUSAN: Aripiprazole Lauroxil; RDC-3317
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number265
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namearipiprazole
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameover-encapsulated aripiprazole
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    stable schizophrenia
    E.1.1.1Medical condition in easily understood language
    mental disease called schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10009134
    E.1.2Term Chronic schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10039632
    E.1.2Term Schizophrenia NOS
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the safety of ALKS 9072 during long-term treatment of subjects with stable
    schizophrenia.
    E.2.2Secondary objectives of the trial
    To evaluate the durability of effect of ALKS 9072 during long-term treatment of subjects with
    stable schizophrenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects Who Participated in ALK9072-003
    1. Subject completed the ALK9072-003 Day 85 visit
    2. Subject continues to require chronic treatment with an antipsychotic medication, in the opinion of the investigator
    3. Subject continues to meet the contraceptive requirements of the study (see Section 7.5.1)
    4. Subject is willing to continue, and has provided informed consent before initiation of any study specific procedures

    New Subjects (Not Participated in ALK9072-003)
    1. Subject is between 18 and 70 years old, inclusive, at screening
    2. Subject is on a stable dose of oral antipsychotic medication and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
    3. Subject has a diagnosis of chronic schizophrenia (based on DSM-IV-TR criteria) that is clinically stable as evidenced by:
    - No hospitalizations for acute exacerbations of schizophrenia within 3 months before
    screening
    - CGI-S score of ≤ 3 (mild) at screening
    4. Subject has previously had a clinically significant beneficial response (improvement in
    schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
    5. Subject has been able to achieve outpatient status for more than 3 consecutive months in the past year
    6. Subject has a PANSS total score of less than 70 at screening
    7. Subject has a BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening
    8. Subject resides in a stable living situation, in the opinion of the investigator
    9. Subject has an identified reliable informant, in the opinion of the investigator
    10. Subject meets contraceptive requirements defined in the protocol (see Section 7.5.1)
    11. Subject is fluent (oral and written) in the language in which standardized tests will be administered, and can be reliably rated
    12. Subject is willing and able to provide informed consent and subject has signed the informed consent form before initiation of any study specific procedures
    E.4Principal exclusion criteria
    Subjects Who Participated in ALK9072-003
    1. Subject had an abnormal clinical laboratory, vital sign, or ECG finding during participation in
    study ALK9072-003 that was clinically relevant and related to study drug, in the opinion of the
    investigator
    2. Subject was withdrawn from study ALK9072-003 due to a severe AE or a SAE, or
    because of development of a serious medical condition or serious tolerability issues
    3. Subject missed more than 1 scheduled study visit during participation in study ALK9072-003
    4. Subject has a significant or unstable medical condition that would preclude safe completion of the current study
    5. Subject requires use of a prohibited concomitant medication
    6. Subject is pregnant or breastfeeding

    New Subjects (Not Participated in ALK9072-003)
    1. Subject has a history of poor or inadequate clinical response to treatment with aripiprazole
    2. Subject has a history of treatment resistance, defined as failure to respond to 2 adequate trials of different antipsychotic medications (a minimum of 4 weeks at the subject's maximum tolerated dose)
    3. Subject has a history of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, tardive dystonia, or other medical condition that would convey undue risk or interfere with study assessments
    4. Subject has clinically significant extrapyramidal symptoms at screening or baseline
    5. Subject is at significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator
    6. Subject answers “Yes” on items 4 or 5 of the C-SSRS (ideation) with the most recent episode occurring within the past 2 months, or answers “Yes” to any of the 5 items (behavior) with an episode occurring within the last year
    7. Subject has a diagnosis (according to DSM-IV-TR criteria) of substance (including alcohol)
    dependence currently or within 6 months before screening or abuse within 3 months before
    screening (exception: nicotine and caffeine dependence are allowed)
    8. Subject has comorbid schizoaffective disorder, bipolar disorder, major depressive disorder,
    dementia, delirium, amnestic or any other cognitive disorder currently or within the past 2 years
    9. Subject has a clinically significant or unstable medical illness/condition/disorder that would be
    anticipated, in the investigator’s opinion, to potentially compromise subject safety or adversely
    affect the evaluation of durability of effect
    10. Subject has clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction
    defect, history of myocardial infarction or unstable angina within the last 3 months before
    screening, or clinically significant abnormality on screening or baseline ECG including but not
    limited to the following: QTcF > 465 msec for
    11. Subject has a laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the subject, or any of the following laboratory abnormalities at screening or baseline:
     AST or ALT value ≥ 2 times the upper limit of the laboratory normal reference range
     HbA1c > 9%
     Absolute neutrophil count </=1.5 x 1000/L
     Platelet count </=75 x 1000/L
     Serum creatinine > 2.5 mg/dL
     Positive test result for HIV, Hbs-Ag, or antihepatitis C virus antibody
     Urine drug screen at screening or baseline indicates illicit substance use with a positive
    result for any of the tested substances
     Exception: results positive for benzodiazepines, opiates, or barbiturates may not be
    exclusionary if the investigator confirms that such medication was medically indicated
    and consults the INC Research medical monitor before enrolling a subject with such a
    finding
    12. Subject is pregnant, lactating, or breastfeeding
    13. Subject has inadequate gluteal muscle or excessive gluteal fat, as determined by the investigator, that would interfere with gluteal IM injection using a 1.5 or 2-inch needle
    14. Subject has received any long-acting IM antipsychotic medication within 2 injection cycles before screening
    15. Subject has used a prohibited medication
    16. Subject is currently under involuntary hospitalization
    17. Subject is currently incarcerated, expects to be incarcerated in the next 12 months, or has pendinglegal action which may impact compliance with participation in this study or study procedures
    18. Subject is currently participating in or has recently participated in another clinical trial in which the
    subject received an experimental or investigational drug or agent within 3 months before screening
    E.5 End points
    E.5.1Primary end point(s)
    Safety evaluations: will include the number and percentage of subjects with treatment-emergent AEs (TEAEs), as well as changes from baseline in and/or development of potentially clinically significant findings pertaining to the following during the treatment period: vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) and weight, laboratory test results (hematology panel, serum chemistry panel [including glucose, high- and low-density lipoproteins, total cholesterol, and HbA1c] and urinalysis), 12-lead ECG, abnormal movement scales (AIMS, BARS, and SAS), physical examinations, and development of injection site reactions. Furthermore, the C-SSRS will be performed and concomitant medications will be recorded.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at all study visits
    E.5.2Secondary end point(s)
    Durability of effect evaluations will include the following: Positive and Negative Syndrome Scale
    (PANSS) total score and positive, negative, and general psychopathology subscale scores; CGI-I score and CGI-S score; PANSS response (PANSS total score ≥ 30% decrease [improvement of symptoms] from baseline); overall response (PANSS total score ≥ 30% decrease [improvement of symptoms] from baseline or CGI-I score of 2 [much improved] or 1 [very much improved]); relapse (PANSS total score increase of ≥ 30% from baseline or rehospitalization for psychotic symptoms or use of adjunctive antipsychotic medication after stabilization); remitters (defined as the simultaneous attainment of a score of ≤ 3 for 6 months or more on 8 main items of the PANSS); and time to discontinuation.
    Other evaluations include PSP, EQ-5D-5L, SF-36v2, and concomitant antipsychotic medication use.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at all visits
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    extension study; for pts rolling over from ALK9072-003 study -double blinded;new pts - open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Malaysia
    Philippines
    Romania
    Russian Federation
    Serbia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to the standard of care and based on the treating physician judgement.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-28
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