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    Summary
    EudraCT Number:2012-003445-15
    Sponsor's Protocol Code Number:ALK9072-003
    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:2012-11-01
    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 number2012-003445-15
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects with Acute Exacerbation of Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess how safe and efficient ALKS 9072 is for the treatment of acute exacerbation of schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberALK9072-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01469039
    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 placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntramuscular use
    D.8 Placebo: 2
    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
    acute exacerbation of 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001064
    E.1.2Term Acute schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10046152
    E.1.2Term Unspecified schizophrenia, chronic state with acute exacerbation
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039630
    E.1.2Term Schizophrenia exacerbated
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of ALKS 9072 for the treatment of schizophrenia in subjects experiencing an acute exacerbation
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of ALKS 9072
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genotype Sampling: If a subject consents, a second sample will be collected and stored for future use to explore potential genetic associations with efficacy, adverse effects, symptoms or outcomes.
    E.3Principal inclusion criteria
    1.Willing and able to provide informed consent; subject has signed the informed consent form before initiation of any study specific procedures
    2.Male or female age 18 to 70 years
    3.Diagnosis of schizophrenia according to DSM-IV-TR criteria
    -Currently experiencing an acute exacerbation or relapse with onset of less than 2 months prior to screening
    -If inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation
    - ≥ 2 years have elapsed since initial onset of active-phase schizophrenia symptoms
    4.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.Has been able to achieve outpatient status for more than 3 months in the past year
    6.PANSS that meets the following criteria at screening and baseline:
    •Total score between 70 and 120, inclusive
    •Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:
    o Item 1 (P1; delusions)
    o Item 2 (P2; conceptual disorganization)
    o Item 3 (P3; hallucinatory behavior)
    o Item 6 (P6; suspiciousness/persecution)
    7.GI-S score ≥ 4 at screening and baseline
    8.BMI of 18.5 to 40.0 kg/m2 (inclusive)
    9.Resides in a stable living situation, in the opinion of the investigator
    10.Has an identified reliable informant, in the opinion of the investigator
    11. Meets contraceptive requirements defined in the protocol
    12. Fluent (oral and written) in the language in which standardized tests will be administered, and can be reliably rated
    13. Willing and able to be confined to an inpatient study unit for 2 weeks (or longer if clinically indicated)
    E.4Principal exclusion criteria
    1. History of poor or inadequate clinical response to treatment with aripiprazole
    2. 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. Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its excipients, other antipsychotic agent, or INTRALIPID® (including peanuts, soy, egg, or glycerol)
    4.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. Clinically significant extrapyramidal symptoms at screening or baseline
    5.Answer “Yes” on items 4 or 5 of the C-SSRS (ideation) with the most recent episode occurring within the past 2 months, or answer “Yes” to any of the 5 items (behavior) with an episode occurring within the last year
    6.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 are allowable)
    7.Comorbid neuropsychiatric disorders including;
    • Life time diagnosis of schizoaffective disorder or bipolar disorder, or current, untreated or unstable major depressive disorder.
    • Clinically significant cognitive difficulties including dementia, delirium, or amnestic syndromes that have been present within the past 2 years and would interfere with participation in the study.
    • Any other psychiatric condition that would, in the judgment of the investigator, interfere with participation in the study.
    8. 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 efficacy, including (but not necessarily limited to) the following:
    •Clinically significant hypotension or hypertension not stabilized by medical therapy
    •Unstable thyroid dysfunction in the past 6 months
    • Insufficiently controlled diabetes mellitus in the judgment of the investigator
    •Clinically significant renal insufficiency
    •Malignant tumor within the last 5 years
    •Neurologic conditions including the following:
    −History of seizure disorder or condition associated with seizures
    −History of brain tumor, subdural hematoma or other clinically significant neurological condition within the past 12 months
    −Head trauma with loss of consciousness within 12 months before screening
    −Active acute or chronic central nervous system infection
    −Stroke within 6 months before screening
    •Cardiac conditions including the following:
    •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 if male or >485 msec if female
    9. Laboratory abnormality that, in the opinion of the investigator, or any of the following laboratory abnormalities at screening or baseline:
    •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value ≥2 times the upper limit of the laboratory normal reference range
    •Hemoglobin A1c (HbA1c) >9%
    • Absolute neutrophil count ≤ 1.5 × 103 μL
    •Platelet count ≤ 75 × 103 μL
    •Serum creatinine > 2.5 mg/dL
    •Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or anti-hepatitis C virus antibody
    •Positive pregnancy test result
    •Urine drug screen at screening or baseline shows a positive result for any of the tested substances
    −Exception: results positive for benzodiazepine or opiates 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.
    10. Pregnant, lactating, or breastfeeding
    11. 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
    12. Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening
    13. Use of a prohibited medication
    14. Current involuntary hospitalization or incarceration
    15. Hospitalized for more than 30 days during the 90 days before screening
    16. Participation in another clinical trial in which the subject received an experimental or investigational drug or agent within 6 months before screening
    17. Participation in a clinical study with ALKS 9072 at any time
    18. Study site personnel and/or persons employed by Alkermes or INC Research or by the investigator or study site, or is an immediate family member of such persons
    E.5 End points
    E.5.1Primary end point(s)
    •PANSS total score change from baseline to Day 85
    (PANSS total score is defined as the sum of scores on the PANSS positive, negative, and general psychopathology subscale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 1, Day 8, Day 15, Day 22, Day 29, Day 57,Day 85
    E.5.2Secondary end point(s)
    • Clinician Global Impression - Improvement (CGI-I) scores at Day 85
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 8, Day 15, Day 22, Day 29, Day 57,Day 85
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 different doses of ALKS 9072
    E.8.2.4Number of treatment arms in the trial3
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 90
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 540
    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.
    Another option is subjects who successfully complete the Day 85 visit of the study ALK9072-003 and continue to meet eligibility criteria and sign an informed consent form are eligible to enroll in an extension study under protocol ALK9072-003EXT.
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-11
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