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    Summary
    EudraCT Number:2015-003513-24
    Sponsor's Protocol Code Number:IN11004OLE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-05
    Trial 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 number2015-003513-24
    A.3Full title of the trial
    An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
    Studio in aperto, multicentrico, di follow-up concepito per valutare gli effetti a lungo termine di AP-CD/LD in soggetti con morbo di Parkinson che hanno completato lo studio IN 11 004
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004
    Studio in aperto di estensione e follow up dello studio IN 11 004
    A.3.2Name or abbreviated title of the trial where available
    OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004
    Studio in aperto di estensione e follow up dello studio IN 11 004
    A.4.1Sponsor's protocol code numberIN11004OLE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02615873
    A.5.4Other Identifiers
    Name:IN11004OLENumber:NA
    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 SponsorINTEC PHARMA LTD
    B.1.3.4CountryIsrael
    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 supportIntec Pharma, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntec Pharma, Ltd.
    B.5.2Functional name of contact pointClinical Affairs
    B.5.3 Address:
    B.5.3.1Street Address12 Hartom St., P.O. Box 45219
    B.5.3.2Town/ cityJerusalem
    B.5.3.3Post code9777512
    B.5.3.4CountryIsrael
    B.5.4Telephone number0097225864657
    B.5.5Fax number0097225869176
    B.5.6E-maillinda@intecpharma.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 nameAccordion Pill ¿ Carbidopa/Levodopa 50/400 mg
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCARBIDOPA
    D.3.9.2Current sponsor coden/a
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.2Current sponsor coden/a
    D.3.9.4EV Substance CodeSUB08468MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameAccordion Pill ¿ Carbidopa/Levodopa 50/500 mg
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCARBIDOPA
    D.3.9.2Current sponsor coden/a
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.2Current sponsor coden/a
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Parkinson's Disease
    Morbo di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    Morbo di Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    E.1.2System Organ Class 100000004852
    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 long-term safety and tolerability of AP-CD/LD in
    subjects with advanced PD who completed the core study IN 11 004.
    Determinare la sicurezza e tollerabilità a lungo termine di AP-CD/LD in soggetti con MP avanzato che hanno completato lo studio principale IN 11 004
    E.2.2Secondary objectives of the trial
    The secondary objective to determine the long-term clinical benefit of
    AP-CD/LD in subjects with advanced PD who completed the core study
    IN 11 004.
    L’obiettivo secondario è determinare il beneficio clinico a lungo termine di AP-CD/LD in soggetti con MP avanzato che hanno completato lo studio principale IN 11 004
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who successfully completed the core study IN 11 004 and,
    in the opinion of the Investigator would benefit from long-term
    treatment with AP-CD/LD
    2. Subjects who have a good response to levodopa in the opinion of the
    investigator
    3. Subjects able and willing to give written (signed and dated) informed
    consent to participate in the study
    1. Soggetti che hanno completato con successo lo studio
    principale IN 11 004 e che, secondo il giudizio dello sperimentatore, trarrebbero beneficio dal trattamento a lungo termine con AP-CD/LD.

    2. Soggetti per i quali, nel parere dello sperimentatore, hanno una buona risposta a Levodopa

    3. Soggetti capaci e disposti a fornire il consenso informato scritto (firmato e datato)
    per partecipare allo studio
    E.4Principal exclusion criteria
    1. Participation in a clinical trial other than study IN 11 004 and receipt
    of an investigational medication other than those administered in study
    IN 11 004, within 28 days prior to the planned start of treatment
    2. Previous or planned functional neurosurgical or Duodopa treatment
    for Parkinson's Disease (e.g., procedures including ablation or deep
    brain stimulation)
    3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days
    prior to Baseline Visit or planned administration during study
    participation.
    4. If, in the opinion of the Investigator, subject should not participate in the study
    5. Women who are pregnant or nursing. Women of childbearing
    potential who are not willing to use a medically acceptable method of
    contraception. Medically acceptable methods of contraception that may
    be used by the subject and /or partner include: True abstinence when
    this is in line with the preferred and usual lifestyle of the subject, oral
    contraceptive agents, intrauterine devices (IUDs), implantable
    contraceptives (e.g., Norplant), transdermal hormonal contraceptives
    (e.g., Ortho-Evra), and injectable contraceptives (e.g., Depo-Provera),
    condom and /or diaphragm, diaphragm with vaginal spermicide, surgical
    sterilization (6 months), or postmenopausal females (no menstrual
    period for > 2years) or vasectomy ( > 6 months) . The current
    contraceptive therapy must be maintained through the end of the study
    (End of study visit or final follow-up phone visit, whichever is later).
    Hormonal contraceptive therapy must be a stable dose for at least 90
    days prior to first study drug administration.
    1. Partecipazione a un'altra sperimentazione clinica e assunzione di un
    farmaco sperimentale nei 28 giorni precedenti all'inizio programmato del
    trattamento (è richiesta la precedente partecipazione alla
    sperimentazione clinica IN 11 004)

    2. Precedente o pianificato trattamento neurochirurgico funzionale o con Duodopa per il Morbo di Parkinson (es. interventi che prevedono l’ablazione o la stimolazione cerebrale profonda) durante la partecipazione allo studio
    3. Farmaci concomitanti non steroidei anti-infiammatori (FANS) e steroidi per via orale entro 90 giorni prima della visita basale o somministrazioni concomitanti pianificate durante la partecipazione allo studio.

    4. Inibitori non selettivi della monoamino-ossidasi (MAO) nei 28 giorni precendenti la
    visita basale o somministrazioni pianificate durante la partecipazione allo studio

    5. Donne in gravidanza o in allattamento. Donne in età fertile non disposte ad adottare un metodo contraccettivo accettabile dal punto di vista medico. I metodi contraccettivi accettabili dal punto di vista medico che possono essere utilizzati dal soggetto e/o dal/dalla partner includono astinenza totale, se in linea con lo stile di vita preferito e abituale del soggetto, agenti contraccettivi orali, dispositivi intrauterini (intrauterine devices, IUD), contraccettivi impiantabili (es. Norplant), contraccettivi ormonali transdermici (es. Ortho-Evra) e contraccettivi iniettabili (es. Depo-Provera), profilattico e/o diaframma, diaframma con spermicida vaginale, sterilizzazione chirurgica (6 mesi), donna in fase postmenopausale (nessun ciclo mestruale per >2 anni) o vasectomia (>6 mesi). La terapia contraccettiva in corso deve essere mantenuta per tutta la durata dello studio (visita di fine studio o visita telefonica di follow-up finale, a seconda di quale evento si verifichi per ultimo). La terapia contraccettiva ormonale deve essere somministrata a dose stabile per un minimo di 90 giorni precedenti la prima somministrazione del farmaco dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Adverse Events
    2. Specific evaluation of GI complaints (Adverse events of special
    interest)
    3. Withdrawal rates, days and reason to withdrawals
    4. Safety laboratory (hematology, biochemistry, Vitamin B12, Folic Acid
    and urinalysis)
    5. Vital signs
    6. Electrocardiogram (ECG)
    7. Physical examination
    8. Orthostatic hypotension evaluation
    9. Evaluation of suicidality using the Columbia Suicide Severity Rating
    Scale (C-SSRS) baseline (Visit 1) to EOS (Visit 7) visit
    10. Assessment of impulse control using the Questionnaire for
    Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale
    (QUIP-RS)
    11. Change from baseline (Visit 1) to EOS (Visit 7) visit in the Scales for
    Outcomes in Parkinson's Disease - Epworth Sleepiness Scale (ESS)
    1. Eventi avversi
    2. Valutazione specifica di disturbi gastrointestinali (GI) (eventi avversi di interesse speciale)
    3. Percentuali di ritiro, giorni e motivi del ritiro
    4. Esami di laboratorio di sicurezza (ematologica, biochimica, vitamina B12, acido folico e analisi delle urine)
    5. Segni vitali
    6. Elettrocardiogramma (ECG)
    7. Esame obiettivo
    8. Valutazione dell’ipotensione ortostatica
    9. Valutazione della tendenza al suicidio mediante la Scala di valutazione della gravità del rischio di suicidio della Columbia University (Columbia Suicide Severity Rating Scale, C-SSRS) dalla visita basale (Visita 1) alla visita di fine studio (End of Study, EOS) (Visita 7)
    10. Valutazione del controllo degli impulsi mediante il questionario con scala di valutazione dei disturbi impulsivo-compulsivi nel morbo di Parkinson (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale, QUIP-RS)
    11. Variazione dalla visita basale (Visita 1) alla visita di EOS (Visita 7) nelle scale relative agli esiti del morbo di Parkinson - scala della sonnolenza di Epworth (Epworth Sleepiness Scale, ESS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    On an ongoing basis
    in via continuativa
    E.5.2Secondary end point(s)
    Efficacy Outcome Measures: The following efficacy endpoints are predefined
    as secondary endpoints for approximately the first 150 enrolled
    patients.
    1. Change from Baseline to EOS in the percentage and total hours of
    daily "Off time" during waking hours based on Hauser Home Diary
    assessments; Total number of "Off " hours normalized to a 16- hour
    waking day will also be calculated but only a single p-value applicable to
    both the percentage and hours will be reported.
    2. Change from Baseline to EOS in "On time" without troublesome
    dyskinesia during waking hours
    3. Change from Baseline to EOS in the number of daily Levodopa doses
    4. CGI-I at EOS as recorded by physician (all enrolled patients)
    5. CGI-I at EOS as recorded by patient (all enrolled patients)
    6. Change from Baseline in total UPDRS Score (Sum of Parts I-III)
    7. Change from Baseline to EOS in UPDRS Part II (Activities of Daily
    Living) 8. Change from Baseline to EOS in UPDRS Motor Examination (part III -
    evaluated 2-3 hours after last LD dose)
    9. Change from Baseline to EOS in PDQ-39 summary index
    10. Change from Baseline to EOS in troublesome dyskinesia
    11. Change from Baseline to EOS in "On time" without dyskinesia
    during waking hours.
    In addition, the following exploratory efficacy endpoints will be
    evaluated.
    • Change from Baseline to EOS in the Parkinson's Disease Sleep Scale
    (PDSS-2)
    • Change from Baseline to EOS (hours during waking time) for each
    diary category not listed as secondary endpoint
    • Change from Baseline to EOS in the Freezing of Gait
    • Change from Baseline to EOS in Morning Akinesia
    • Change from Baseline to EOS of percentage of time during waking
    hours of each diary category excluding sleep time and "Off time"
    • Change from Baseline to EOS in UPDRS part IV, evaluated as
    dyskinesia sum score (sum of items 32-35) and wearing-off sum score
    (sum of items 36-39)
    Esito delle misure di Efficacia: I seguenti endpoint di efficacia sono predefiniti
    come endpoint secondari per questo studio esclusivamente per i primi circa 150
    pazienti circa arruolati.
    1. Variazione dal basale all’EOS nella percentuale e nelle ore totali di “periodo off” giornaliero durante le ore di veglia in base alle valutazioni del Diario di Hauser a domicilio; sarà calcolato anche il numero totale di ore “off” normalizzato rispetto a un giorno di veglia di 16 ore, ma verrà riportato soltanto un singolo valore p applicabile sia alla percentuale che alle ore
    2. Variazione dal basale all’EOS nel “periodo on” senza discinesia fastidiosa durante le ore di veglia
    3. Variazione dal basale all’EOS nel numero di dosi giornaliere di Levodopa
    4. Scala di impressione clinica globale sul miglioramento (Clinical Global Impression-Improvement, CGI-I) all’EOS registrata dal medico (tutti i pazienti arruolati)
    5. CGI-I all’EOS registrata del paziente (tutti i pazienti arruolati)
    6. Variazione rispetto al basale nel punteggio totale della Scala di valutazione unificata del morbo di Parkinson (Unified Parkinson's Disease Rating Scale, UPDRS) (somma delle Parti I-III)
    7. Variazione dal basale all’EOS nella Parte II dell’UPDRS (attività quotidiane)
    8. Variazione dal basale all’EOS nell’esame motorio dell’UPDRS (Parte III - valutata 2-3 ore dopo l’ultima dose di LD)
    9. Variazione dal basale all’EOS nel Questionario sul morbo di Parkinson a 39 voci (Parkinson’s Disease Questionnaire – 39 items, PDQ-39)
    10. Variazione dal basale all’EOS nella discinesia fastidiosa
    11. Variazione dal basale all’EOS nel “periodo on” senza discinesia durante le ore di veglia.

    In aggiunta, saranno valutati i seguenti endpoint esplorativi di efficacia.
    • Variazione dal basale all’EOS nella Scala del sonno nel morbo di Parkinson (Parkinson's Disease Sleep Scale, PDSS-2)
    • Variazione dal basale all’EOS (ore durante il periodo di veglia) per ciascuna categoria del diario non elencata come endpoint secondario
    • Variazione dal basale all’EOS nel freezing della deambulazione
    • Variazione dal basale all’EOS nell’acinesia mattutina
    • Variazione dal basale all’EOS nella percentuale di tempo durante le ore di veglia di ciascuna categoria del diario, esclusi il periodo di sonno e il “periodo off”
    • Variazione dal basale all’EOS nella Parte IV dell’UPDRS, valutata come punteggio totale di discinesia (somma delle voci 32-35) e punteggio totale di deterioramento da fine dose (somma delle voci 36-39)
    E.5.2.1Timepoint(s) of evaluation of this end point
    On an ongoing basis
    In continuo
    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 No
    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 No
    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
    NA
    NA
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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 Information not present in EudraCT
    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
    Germany
    Israel
    Italy
    Poland
    Slovakia
    Spain
    Ukraine
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 266
    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)
    Eligible subjects will have the opportunity to participate in an open-label extension study. Ineligible subjects or those who do not wish to enter the open-label extension study will return to the standard treatment for their condition.
    I Soggetti eleggibili avranno la possibilità di partecipare ad uno studio in aperto di estensione. I Soggetti non ammissibili o coloro che non desiderano entrare nello studio in aperto di estensione torneranno al trattamento atteso per la loro condizione.
    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 Decision2016-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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