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    Summary
    EudraCT Number:2012-002840-26
    Sponsor's Protocol Code Number:PD0005
    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:2013-01-11
    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 number2012-002840-26
    A.3Full title of the trial
    A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD
    STUDIO DI FASE 4, MULTICENTRICO, MULTINAZIONALE, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, A TRE BRACCI PER VALUTARE L'EFFICACIA DELLA ROTIGOTINA SUI SINTOMI MOTORI, L'APATIA E L'™UMORE ASSOCIATI ALLA MALATTIA DI PARKINSON
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease
    Studio per testare l'efficacia di due dosi di Rotigotina sull'umore depressivo (apatia) associato con la malattia di Parkinson
    A.4.1Sponsor's protocol code numberPD0005
    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 SponsorUCB BIOSCIENCES GMBH
    B.1.3.4CountryGermany
    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 supportUCB Biosciences GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GMBH
    B.5.2Functional name of contact pointna
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 481107
    B.5.5Fax number+49 2173 481608
    B.5.6E-mailAstrid.Meyer@ucb.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 Yes
    D.2.1.1.1Trade name Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 8
    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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Degenerative disease of the nervous system
    malattia degenerativa del sistema nervoso
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system 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 assess the effects of rotigotine over placebo on improvement of
    apathy and motor symptoms in subjects with early-stage and advanced
    stage idiopathic Parkinson's disease
    dimostrare che la rotigotina migliora l’apatia e i sintomi motori rispetto al placebo nei soggetti affetti da malattia idiopatica di Parkinson in fase iniziale e avanzata.
    E.2.2Secondary objectives of the trial
    To evaluate the change in quality of life, anhedonia, depressive symptoms, fatigue, cognitive impairment, apathy rated by the caregiver, safety, and tolerability in subjects with apathy in early-stage and advanced-stage idiopathic Parkinson's disease
    valutazione del cambiamento in termini di qualità della vita, anedonia, sintomi depressivi, affaticamento, deficit cognitivo, apatia valutata dall’assistente (caregiver), sicurezza e tollerabilità nei soggetti con apatia nella malattia idiopatica di Parkinson in fase iniziale e avanzata.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee
    (IEC) approved written Informed Consent form is signed and dated by
    the subject. 2. Subject is considered reliable and capable of adhering to the protocol, visit schedule or medication application according to the judgment of the investigator. 3. Subject is male or female and ≥ 18 years old at the Screening Visit. 4. Subject has idiopathic Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following:
    resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of parkinsonism. 5. Subject has unsatisfactory control of Parkinson's disease motor symptoms under the current treatment, according to the judgment of the investigator.
    6. Subject has a Hoehn and Yahr stage score I-IV during the "on" state
    at the Screening Visit.7. If subject is taking levodopa, he/she must be on a stable dose of levodopa (in combination with benserazide or carbidopa) for at least 28
    days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study. 8. Subject suffers from apathy associated with Parkinson's disease for at least 3 months, evidenced by a score of ≥ 2 on UPDRS Part I Item 4 at
    the Screening Visit and an average of at least ≥ 14 on the AS at the Screening and Baseline Visit as rated by the subject.
    9. Subject has a Mini-Mental State Examination (MMSE) score ≥ 25 at the
    Screening Visit.10. If the subject is receiving an anticholinergic agent, a monoamineoxidase (MAO) B-inhibitor, the Catechol-O-Methyl Transferase (COMT)inhibitor entacapone, or the N Methyl D Aspartate (NMDA) antagonist
    amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study. 11. If subject is taking an antidepressant drug, such as selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine
    reuptake inhibitors (SNRIs), bupropion, or tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study.
    12. Female subjects must be either postmenopausal for at least 1 year,
    surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable
    hormonal contraceptives, intrauterine device, or barrier and spermicide).
    Abstinence only is not an acceptable method. Subjects must agree to use
    adequate contraception during the study and for 4 weeks after their final
    dose of rotigotine (or longer, if required by local regulations).
    1.Un modulo di consenso informato approvato da un Comitato Istituzionale di Revisione (IRB)/Comitato Etico Indipendente (CEI) e firmato e datato dal soggetto. 2.A parere dello sperimentatore, il soggetto è considerato affidabile e in grado di rispettare il protocollo, il programma delle visite o l’applicazione del farmaco. 3.Il soggetto è maschio o femmina di età ≥ 18 anni alla visita di screening. 4.Il soggetto è affetto da malattia idiopatica di Parkinson, definita dal segno cardinale, bradicinesia, più la presenza di almeno 1 dei seguenti sintomi: tremore a riposo, rigidità o compromissione dei riflessi posturali e assenza di qualsiasi altra causa nota o sospetta di parkinsonismo. 5.A parere dello sperimentatore, il soggetto presenta un controllo insoddisfacente dei sintomi motori della malattia di Parkinson con il trattamento corrente. 6.Il soggetto presenta un punteggio della stadiazione di Hoehn e Yahr compreso tra I e IV durante lo stato “on” alla visita di screening. 7.Se il soggetto sta assumendo levodopa, deve avere assunto una dose stabile di levodopa (in combinazione con benserazide o carbidopa) per almeno 28 giorni prima della visita basale e la dose deve essere mantenuta per l’intera durata dello studio. 8.Il soggetto soffre di apatia associata a malattia di Parkinson da almeno 3 mesi, evidenziata da un punteggio ≥ 2 sulla scala UPDRS Parte I Elemento 4 alla visita di screening e una media di almeno ≥ 14 sulla scala AS alla visita di screening e al basale in base alla valutazione del soggetto.9.Il soggetto deve avere un punteggio ≥ 25 sulla scala MMSE (Mini-Mental State Examination) alla visita di screening.10.Se il soggetto sta ricevendo un agente anticolinergico, un inibitore delle monoaminossidasi-B (MAO-B), l’inibitore della catecol-O-metiltransferasi (COMT) entacapone oppure l’antagonista-N-metil-D-aspartato (NMDA) amantandina, deve avere assunto una dose stabile per almeno 28 giorni prima della visita basale e la dose deve essere mantenuta per l’intera durata dello studio. 11.Se il soggetto sta assumendo un farmaco antidepressivo, come ad esempio gli inibitori selettivi della ricaptazione della serotonina, gli inibitori della ricaptazione di serotonina e noradrenalina, bupropione o antidepressivi triciclici, deve avere assunto una dose stabile per almeno 28 giorni prima della visita basale e la dose deve essere mantenuta per l’intera durata dello studio. 12.I soggetti di sesso femminile devono essere in postmenopausa da almeno 1 anno, sterilizzate chirurgicamente oppure devono utilizzare un metodo contraccettivo accettabile ed efficace (contraccettivi ormonali orali/parenterali/impiantabili, dispositivo intrauterino o barriera e spermicida). L’astinenza da sola non costituisce un metodo anticoncezionale accettabile. I soggetti devono accettare di utilizzare un metodo contraccettivo adeguato durante lo studio e per 4 settimane dopo la dose finale di rotigotina (o più a lungo, se richiesto dalle normative locali).
    E.4Principal exclusion criteria
    1.Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study. 2.Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 28 days prior to the Screening Visit or is currently participating in another study of an IMP or a medical device. 3. Subject has had prior therapy with a dopamine agonist within 28 days prior to the Baseline Visit. 4. Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator. 5. Subject has a history of chronic alcohol or drug abuse within the last 6 months. 6.Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations, or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study. 7.Subject has received neuroleptics (except clozapine and quetiapine), dopamine releasing substances (eg, methylphenidate or amphetamine), dopamine modulating substances (eg, reserpine), alpha-methyldopa, metoclopramide, MAO-A inhibitors, budipine, or tolcapone within 28 days of the Baseline Visit. 8. Subject has received electroconvulsive therapy within 12 weeks prior to the Screening Visit. 9. Subject is receiving current psychotherapy or behavior therapy while participating in this study. 10. Subject has a history of deep brain stimulation. 11. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in the protocol. 12. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications. 13. Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit. 14. Subject has an atypical Parkinson’s disease syndrome due to drugs (eg, neuroleptics, metoclopramide, flunarizine), metabolic neurogenetic disorders (eg, Wilson Disease), encephalitis, cerebrovascular disease, or degenerative diseases (progressive supranuclear palsy). 15. Subject has evidence of an impulse control disorder (ICD) according to the modified Minnesota Impulsive Disorders Interview (mMIDI) at the Screening Visit confirmed by a positive structured clinical interview. 16. Subject who is currently lactating or pregnant or planning to become pregnant during the duration of the study. 17. Subject diagnosed with severe depression as evidenced by a BDI-II score of ≥29 at the Screening Visit. 18Subject has symptomatic orthostatic hypotension at Screening.
    1. Il soggetto ha partecipato in precedenza a questo studio oppure al soggetto è stato assegnato in precedenza il trattamento in uno studio sul farmaco sperimentale oggetto del presente studio. 2. Il soggetto ha partecipato a un altro studio su un prodotto medicinale sperimentale (investigational medicinal product, IMP) oppure un dispositivo medico nei 28 giorni precedenti la visita di screening oppure sta attualmente partecipando a un altro studio relativo a un IMP o un dispositivo medico. 3. Il soggetto ha ricevuto in precedenza una terapia con un agonista della dopamina nei 28 giorni precedenti la visita basale. 4. Il soggetto ha interrotto la terapia precedente con un agonista della dopamina dopo un adeguato periodo di trattamento, a un dosaggio adeguato, a causa dell’inefficacia stabilita dalla valutazione dello sperimentatore. 5. Il soggetto presenta un’anamnesi di abuso cronico di alcol o droghe negli ultimi 6 mesi. 6. Il soggetto presenta una condizione medica o psichiatrica (ovvero, disturbo bipolare, demenza, allucinazioni o psicosi) che, a parere dello sperimentatore, potrebbe pregiudicare o compromettere la capacità del soggetto di partecipare a questo studio. 7. Il soggetto ha ricevuto neurolettici (ad eccezione di clozapina e quetiapina), sostanze che favoriscono il rilascio di dopamina (es. metilfenidato o anfetamine), sostanze dopaminergiche (es. reserpina), alfa-metildopa, metoclopramide, inibitori delle MAO-A, budipina o tolcapone nei 28 giorni precedenti la visita basale. 8. Il soggetto ha ricevuto terapia elettroconvulsivante nelle 12 settimane precedenti la visita di screening. 9. Il soggetto è sottoposto a psicoterapia o a terapia comportamentale durante la partecipazione a questo studio. 10. Il soggetto presenta un’anamnesi di stimolazione cerebrale profonda.11. Il soggetto presenta una ipersensibilità nota a uno qualsiasi dei componenti dell’IMP o dei farmaci comparativi come indicato nel protocollo. 12. Il soggetto è affetto da una malattia della pelle significativa tale da rendere inappropriato l’uso del farmaco transdermico, compresa un’anamnesi di sensibilità cutanea agli adesivi o ai farmaci transdermici. 13. Il soggetto presenta un’anamnesi di tentato suicidio nell’arco della sua vita (compreso un tentativo attivo, un tentativo interrotto o un tentativo fallito) oppure ha avuto idee suicide negli ultimi 6 mesi, come indicato da una risposta positiva (“Sì”) alla Domanda 4 o alla Domanda 5 della scala di valutazione C-SSRS (Columbia-Suicide Severity Rating Scale) alla visita di screening. 14. Il soggetto presenta una sindrome atipica della malattia di Parkinson a causa dei farmaci (es. neurolettici, metoclopramide, flunarizina), disturbi neurogenetici metabolici (es. morbo di Wilson), encefalite, malattia cerebrovascolare o malattie degenerative (paralisi sopranucleare progressiva). 15. Il soggetto presenta evidenze di un disturbo del controllo degli impulsi (DCI) in base alla scala mMIDI (modified Minnesota Impulsive Disorders Interview) alla visita di screening, confermato da un’intervista clinica strutturata positiva. 16. Il soggetto è attualmente in allattamento o in gravidanza o sta pianificando una gravidanza durante lo studio. 17. Al soggetto è stata diagnosticata una depressione grave, evidenziata da un punteggio BDI-II ≥ 29 alla visita di screening. 18. Il soggetto presenta ipotensione ortostatica sintomatica allo screening.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from Baseline to the end of Maintenance Period in the score of
    the AS rated by the subject
    • Change from Baseline to the end of Maintenance Period in the total score of the UPDRS Parts II (ADL) + III (motor subscale)
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio della scala AS in base alla valutazione del soggetto.
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale della scala UPDRS Parte II (ADL) + Parte III (sottoscala motoria).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following titration (7 weeks) and maintainance (12 weeks) periods, 19 weeks total
    Dopo il period di titolazione (7 settimane) e mantenimento (12 settimane), per un totale di 19 settimane
    E.5.2Secondary end point(s)
    • Change from Baseline to the end of Maintenance Period in the score of
    the AS rated by the caregiver (where available)
    • Change from Baseline to the end of Maintenance Period in the sum
    score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)
    • Change from Baseline to the end of Maintenance Period in the sum
    score of domain mood/apathy of the NMSS
    • Change from Baseline to the end of Maintenance Period in the sum
    score of the Snaith Hamilton Pleasure Scale (SHAPS)
    • Change from Baseline to the end of Maintenance Period in the sum
    score of the Beck Depression Inventory (BDI-II)
    • Change from Baseline to the end of Maintenance Period in the sum
    score of the UPDRS Part III (motor subscale) in "on" state
    • Change from Baseline to the end of Maintenance Period in the score of
    the Clinical Global Impressions (CGI) Item I (Severity of Illness)
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio della scala AS in base alla valutazione del caregiver (se disponibile)
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale del questionario a 8 voci sulla malattia di Parkinson (Parkinson’s Disease Questionnaire, PDQ-8).
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale del dominio umore/cognizione della scala NMSS.
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale della scala del piacere di Snaith-Hamilton (Snaith-Hamilton Pleasure Scale, SHAPS).
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale della scala Beck Depression Inventory Second Edition (BDI-II).
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio totale della scala UPDRS Parte III (sottoscala motoria) nello stato “on”.
    • Variazione dal basale alla fine del periodo di mantenimento del punteggio della scala Impressioni cliniche globali (Clinical Global Impressions, CGI) Voce I (Gravità della malattia).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following titration (7 weeks) and maintainance (12 weeks) periods, 19 weeks total
    Dopo il period di titolazione (7 settimane) e mantenimento (12 settimane), per un totale di 19 settimane
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Russian Federation
    Turkey
    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
    LVLS
    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 months32
    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 months32
    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.1.1Number of subjects for this age range: 0
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 349
    F.4.2.2In the whole clinical trial 600
    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)
    The treatment of the subject after the end of study treatment is left to the investigator’s discretion.
    Il trattamento del soggetto dopo la fine del trattamento di studio è lasciata alla discrezione dello sperimentatore
    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 Decision2013-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-04
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