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    Summary
    EudraCT Number:2012-003239-47
    Sponsor's Protocol Code Number:14724B
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003239-47
    A.3Full title of the trial
    Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia
    Studio di estensione, interventistico, in aperto, con dose flessibile di aripiprazolo una volta al mese in pazienti affetti da schizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A continuation of the main study investigating the effects of a monthly dose of aripiprazole on schizophrenia
    Continuazione dello studio principale che indagherà gli effetti di una dose mensile di aripiprazolo sulla schizofrenia
    A.4.1Sponsor's protocol code number14724B
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9, Valby
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4536301311,
    B.5.5Fax number+4536 301940
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 nameLu AF41155
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release 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
    D.3.9.1CAS number 129722-12-9
    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 number400
    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 nameLu AF41155
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release 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
    D.3.9.1CAS number 129722-12-9
    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 number300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    Schizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizofrenia
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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
    Long-term safety and tolerability of aripiprazole once-monthly (400 or 300 mg/month) in patients with schizophrenia who completed Study 14724A.
    valutare la sicurezza e la tollerabilità a lungo termine dell'aripiprazolo una volta al mese
    (400 o 300 mg/mese) in pazienti affetti da schizofrenia, che hanno completato lo studio 14724A.
    E.2.2Secondary objectives of the trial
    - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on subjective treatment satisfaction in patients with schizophrenia who completed Study 14724A.
    - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on clinical global impression in patients with schizophrenia who completed Study 14724A.
    - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on health-related quality of life in patients with schizophrenia who completed Study 14724A.
    –valutare l'efficacia dell'aripiprazolo una volta al mese (400 o 300 mg/mese) in un periodo di 24 settimane in pazienti affetti da schizofrenia, che hanno completato lo studio 14724A, in termini di:
    –soddisfazione oggettiva del trattamento
    –impressione clinica globale
    –qualità della vita correlata alla salute
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
    • The patient agrees to protocol-defined use of effective contraception.
    I pazienti sono stati trattati con aripiprazolo una volta al mese e hanno completato lo studio 14724A.
    I pazienti, secondo il giudizio dello sperimentatore, trarrebbero beneficio dal trattamento di 24 settimane con aripiprazolo una volta al mese.
    I pazienti sono in grado di leggere e comprendere il modulo di consenso informato.
    I pazienti hanno firmato il nuovo modulo di consenso informato specifico di questo studio di estensione, studio 14724B.
    E.4Principal exclusion criteria
    • The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
    • The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
    • The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
    • The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
    • The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
    • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
    -Ai pazienti è stato diagnosticato un disturbo psichiatrico diverso dalla schizofrenia durante lo studio 14724A.
    -I pazienti, secondo il parere dello sperimentatore, sono a rischio significativo di suicidio o, durante la visita basale II, al questionario C-SSRS:
    –Rispondono “Sì” alle domande 4 o 5 della sezione sulle idee suicide, OPPURE
    –Rispondono “Sì” a qualsiasi domanda della sezione sul comportamento suicida.
    •I pazienti manifestano un evento avverso in corso, moderato o grave, correlato al medicinale sperimentale somministrato durante lo studio 14724A, che lo sperimentatore considera essere un rischio potenziale per la sicurezza.

    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    • Safety and tolerability measured with number of adverse events
    • Risk of suicidality measured with Columbia-Suicide Severity Rating Scale (C-SRRS) score
    Sicurezza e tollerabilità misurati con il numero di eventi avversi;
    rischio suicidiario misurato con il punteggio Columbia-Suicide Severity Rating Scale (C-SRRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 weeks and 4-week safety follow up
    Fino a 24 settimane e 4 settimane di follow up di sicurezza
    E.5.2Secondary end point(s)
    • Mean change from Baseline in subjective well-being using SWN-S measured with Subjective Well-being under Neuroleptics - short version (SWN-S) total
    score
    • Mean change from Baseline in clinical global impression measured with Clinical Global Impression - Severity of Illness (CGI-S) score
    • Mean change from Baseline in quality of life measured with Quality of Life Scale (QLS) total score
    • Mean change from Baseline in quality of life using QLS measured with 4 QLS dimension scores
    • Mean change from Baseline in tolerability and quality of life using TooL measured with Tolerability and Quality of Life (TooL) total score
    • Mean change from Baseline to identify individuals with sexual dysfunctionmeasured with Arizona Sexual Experience Scale (ASEX) total score
    • Mean change from Baseline in the patient's readiness to work measured with The Readiness for Work Questionnaire (WoRQ) total score
    •Variazione media dal basale nel benessere soggettivo utilizzando SWN-S misurato con benessere soggettivo sotto neurolettici - versione corta (SWN-S) punteggio totale;
    Variazione media dal basale nel punteggio CGI – S;
    Variazione media dal basale nel quality of life misurato con punteggio totale QLS (Quality of Life Scale);
    Variazione media dal basale dei punteggi di 4 aree del questionario QLS;
    Variazione media dal basale nella tollerabilità e QLS del punteggio totale;
    Variazione media dal basale per individuare individui con disfunzione sessuale con il punteggio totale della “Arizona Sexual Experience Scale” (ASEX);
    Variazione media dal basale nel punteggio del “The Readiness for Work Questionnaire” (WoRQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 24
    Baseline e settimana 24.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparatore dello Studio A non viene utilizzato come obiettivo primario dello Studio B perchè deve e
    Comparator from Study A not used as the primary obj. of Study B is to collect longterm safety data
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    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
    The end of the study for an individual patient is defined as the last protocol-specified contact with that patient. The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.
    La fine dello studio per un paziente è definita come l’ultimo contatto specifico previsto da protocollo con il paziente. La fine generale dello studio è definita come l’ultimo contatto specifico previsto da protocollo con l’ ultimo paziente in corso nello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 100
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 100
    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)
    None
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-01
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