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    Summary
    EudraCT Number:2015-005078-39
    Sponsor's Protocol Code Number:ND0612H-006
    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:2021-01-19
    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 number2015-005078-39
    A.3Full title of the trial
    A multicenter, parallel-group, rater-blinded, randomized clinical study
    investigating the efficacy, safety, tolerability and pharmacokinetics of
    2 dosing regimens of ND0612H, a solution of levodopa/carbidopa
    delivered via a pump system as a continuous subcutaneous infusion in
    subjects with advanced Parkinson's disease
    Studio clinico randomizzato, multicentrico, a gruppi paralleli, con valutatore in cieco, volto a studiare l'efficacia, la sicurezza, la tollerabilit¿ e la farmacocinetica di 2 regimi di dosaggio di ND0612H, una soluzione di levodopa/carbidopa somministrata tramite un sistema di infusione sottocutanea continua a pompa, in soggetti affetti da morbo di Parkinson in fase avanzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberND0612H-006
    A.5.4Other Identifiers
    Name:Non-DisponibileNumber:Non-Disponibile
    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 SponsorNEURODERM 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 supportNeuroDerm Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroDerm Ltd.
    B.5.2Functional name of contact pointYaell Ullmann
    B.5.3 Address:
    B.5.3.1Street Address3 Pekeris St.
    B.5.3.2Town/ cityRehovot
    B.5.3.3Post code7670212
    B.5.3.4CountryIsrael
    B.5.4Telephone number+972-8-9462729
    B.5.5Fax number+972-8-9461729
    B.5.6E-mailullmann.y@neuroderm.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 namesoluzione di levodopa/carbidopa
    D.3.2Product code ND0612
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 38821-49-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 Yes
    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
    advanced Parkinson's disease
    morbo di Parkinson in fase avanzata
    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 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 effect of continuous SC infusion of 2 dosing regimens of ND0612H on daily
    ¿OFF¿ time.
    Valutare l'effetto dell'infusione SC continua di 2 regimi di dosaggio di ND0612H sulle fasi "OFF"
    quotidiane.
    E.2.2Secondary objectives of the trial
    - To assess the difference between the 2 dosing regimens of ND0612H vs.
    standard oral LD/CD treatment on ability to induce early morning full ¿ON¿.
    - To assess the effect of 2 dosing regimens of ND0612H on daily ¿ON¿
    time without dyskinesia and ¿ON¿ time with dyskinesia .
    - To assess the effect of 2 dosing regimens of ND0612H on the motor
    score and activities of daily living (ADL) scores of the Unified Parkinson¿s Disease Rating Scale
    (UPDRS) in comparison to standard oral LD/CD treatment.
    - To assess the Clinical Global Impression (CGI; improvement and severity score assessed by
    investigator), Parkinson¿s Disease Sleep Scale (PDSS), and 39-Item PD Quality of Life [QoL]
    Questionnaire (PDQ-39).
    - To determine the need for rescue doses/dose modifications/additional therapy of standard oral
    LD/CD Immediate Release (IR) and/or entacapone.
    - To profile the pharmacokinetics (PK) of 2 dosing regimens of ND0612H
    - Valutare la differenza tra i 2 regimi di dosaggio di ND0612H vs. il trattamento
    orale std con LD/CD sulla capacit¿ di portare a una fase "ON" completa, la mattina.
    - Valutare l'effetto dei 2 regimi di dosaggio di ND0612H quotidianamente sulle fasi "ON" senza discinesia e sulle fasi "ON" con discinesia.
    - Valutare l'effetto dei 2 regimi di dosaggio di ND0612H sulla capacit¿ motoria e sulle attivit¿ della vita quotidiana, in base ai punteggi della Unified Parkinson¿s Disease Rating Scale rispetto al trattamento orale std con LD/CD.
    - Valutare la Clinical Global Impression (come determinato dallo sperimentatore), la valutazione del sonno attraverso la Parkinson's Disease SleepScale e il questionario a 39 domande relativo alla qualit¿ della vita con il morbo di Parkinson .
    - Determinare la necessit¿ di dosi di soccorso/modifiche della dose/terapie supplementari std di
    LD/CD, per os a rilascio immediato e/o di entacapone.
    - Delineare la PK dei 2 regimi di dosaggio di ND0612H
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female PD subjects of any race aged 30 to 80 years who sign an Institutional Review
    Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF).
    2. PD diagnosis consistent with the UK Brain Bank Criteria.
    3. Modified Hoehn & Yahr scale in “ON” state of stage =3.
    4. Taking at least 4 doses/day of LD (or at least 3 doses/day of Rytary) and taking, or have
    attempted to take, at least 2 other classes of anti-PD medications in a therapeutic dose for at least
    30 consecutive days each.
    5. Subjects must be stable on their anti-PD medications for at least 30 days before Day 1.
    6. Subjects may have had prior exposure to SC apomorphine injections/infusion but must have
    stopped administration at least 4 weeks before the screening visit. Treatment with apomorphine
    is prohibited during the entire ND0612H treatment period.
    7. Must have a minimum of 2.5 hrs of “OFF” time per day with predictable early morning “OFF”
    periods as estimated by the subject.
    8. Must have predictable and well defined early morning “OFF” periods with a good response to
    LD for treatment of the early morning “OFF” in the judgement of the investigator.
    9. Mini Mental State Examination (MMSE) score >26.
    10. No clinically significant medical, psychiatric or laboratory abnormalities which the investigator
    judges would be unsafe or non-compliant in the study.
    11. Female subjects must be surgically sterile, postmenopausal (defined as cessation of menses for at
    least 1 year), or willing to practice a highly effective method of contraception. All female
    participants must be non-lactating and non-pregnant and have a negative urine pregnancy test at
    Screening and at Baseline. Female subjects of childbearing potential must practice a highly
    effective method of contraception (e.g., oral contraceptives, a barrier method of birth control
    [e.g., condoms with contraceptive foams, diaphragms with contraceptive jelly], intrauterine
    devices, partner with vasectomy), 1 month before enrollment, for the duration of the study, and
    3 months after the last dose of study drug.
    12. Willingness and ability to comply with study requirements
    1. Soggetti di sesso maschile e femminile, affetti da morbo di Parkinson, di qualsiasi razza, di età
    compresa tra i 30 e gli 80 anni, firmatari di un modulo di consenso informato (ICF) approvato da
    unComitato etico (EC).
    2. Diagnosi di morbo di Parkinson coerente con il Brain Bank Criteria del Regno Unito.
    3. Scala di fasi "ON" modificata di Hoehn & Yahr, di stadio =3.
    4. Assume almeno 4 dosi al giorno di LD (o almeno 3 dosi al giorno di Rytary) e assume o ha provato ad
    assumere almeno altre 2 classi di farmaci contro il morbo di Parkinson, in dose terapeutica per almeno
    30 giorni consecutivi per ciascuna classe di farmaco.
    5. I soggetti devono presentare stabilità nell'assunzione dei farmaci contro il morbo di Parkinson, almeno nei 30 giorni precedenti il giorno 1.
    6. I soggetti possono essere stati precedentemente sottoposti a iniezioni/infusioni SC di apomorfina, ma la somministrazione deve essere stata interrotta da almeno 4 settimane prima della visita di screening. Il
    trattamento con apomorfina è proibito durante tutto il periodo di trattamento con ND0612H.
    7. Deve avere un minimo di 2,5 ore di fase "OFF" al giorno con prevedibili fasi "OFF" la mattina presto,
    come stimato dal soggetto.
    8. Deve avere fasi "OFF" prevedibili e ben definite la mattina presto, con una buona risposta a LD per il
    trattamento delle fasi "OFF" la mattina presto, a giudizio dello sperimentatore.
    9. Punteggio del test Mini Mental State Examination (MMSE) >26.
    10. Non presenta alcuna anomalia clinicamente significativa dal punto di vista medico, psichiatrico o dei risultati di laboratorio che lo sperimentatore consideri non sicura o non conforme per lo studio.
    11. Le donne partecipanti allo studio devono essere chirurgicamente sterili, in postmenopausa (definita
    come la cessazione delle mestruazioni da almeno 1 anno) o disposte a utilizzare un metodo
    contraccettivo efficace. Le donne partecipanti allo studio non devono allattare al seno né essere in stato di gravidanza e il risultato del test di gravidanza sulle urine allo screening e alla visita basale deve essere negativo. Le donne partecipanti allo studio in grado di procreare devono utilizzare un metodo di contraccezione efficace (ad es. contraccettivi orali, un sistema a barriera di controllo delle nascite [come preservativi con spermicida, diaframmi con gel contraccettivo], dispositivi intrauterini, partner con vasectomia), da 1 mese prima dell'arruolamento, per tutta la durata dello studio e per 3 mesi dopo l'ultima dose del farmaco di studio.
    12. Disponibilità a rispettare le procedure dello studio e capacità di farlo.
    E.4Principal exclusion criteria
    1. Atypical or secondary parkinsonism.
    2. Acute psychosis or hallucinations in past 6 months.
    3. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant
    medication which, in the opinion of the Investigator or the eligibility reviewer, makes the subject
    unsuitable for study entry or potentially unable to complete all aspects of the study.
    4. Prior neurosurgical procedure for PD, or Duodopa treatment.
    5. Subjects with a history of drug abuse or alcoholism within the past 12 months.
    6. Clinically significant ECG rhythm abnormalities.
    7. Renal or liver dysfunction that may alter drug metabolism including: serum creatinine
    >1.3 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x
    upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
    8. Subjects who are not willing to operate the pump system.
    1. Parkinsonismo atipico o secondario.
    2. Episodi di psicosi acuta o allucinazioni negli ultimi 6 mesi.
    3. Qualunque condizione medica, chirurgica o psichiatrica significativa, valore di laboratorio o farmaco
    concomitante che, secondo il parere dello sperimentatore o di chi controlla i criteri di idoneità, rende il
    soggetto inadatto alla partecipazione allo studio o potenzialmente non in grado di completare tutti gli
    aspetti dello studio.
    4. Intervento neurochirurgico per il morbo di Parkinson, o trattamento con Duodopa.
    5. Soggetti con anamnesi clinica di abuso di droghe o alcolismo negli ultimi 12 mesi.
    6. Anomalie nel ritmo dell'elettrocardiogramma clinicamente significative.
    7. Disfunzione renale o epatica che può alterare il metabolismo dei farmaci come: creatinina sierica >1,3
    mg/dl, aspartato aminotransferasi sierica (AST) o alanina aminotransferasi (ALT) >2 x il limite
    superiore della normalità (ULN), bilirubina sierica totale >2,5 mg/dl.
    8. Soggetti che non siano disposti a utilizzare il sistema a pompa.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline to Day 28 in daily “OFF” time (i.e. the phase with no
    response to medication and significant motor symptoms) as assessed by a blinded rater
    L'endpoint primario è la variazione dalla visita basale al giorno 28 nelle fasi "OFF" quotidiane (cioè la fase in cui il soggetto non risponde ai farmaci e presenta significativi sintomi motori) secondo la valutazione di un valutatore in cieco
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Giorno 28
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the percentage of subjects with full ¿ON¿ (i.e. an ¿ON¿ response comparable to the ¿ON¿ response to standard oral LD/CD treatment) at approximately 08:00 and approximately 09:00 on Day 28, as determined by the subject and the blinded rater separately.
    The other secondary endpoints are:
    -Change from baseline to Day 28 in daily ¿ON¿ time without dyskinesia and ¿ON¿ time with
    dyskinesia (mild, moderate, severe) as assessed by a blinded rater, with ¿ON¿ time defined as phase
    with good response to medication and few symptoms.
    - Change from baseline to Day 28 in UPDRS part III (motor) scores, at 4 and 8 hrs post dose/infusion
    start
    - Change from baseline to Day 28 in UPDRS part II (ADL) scores
    - CGI-Improvement (CGI-I) score on Day 28 and change from baseline to Day 28 in CGI-Severity
    (CGI-S) score as assessed by investigator
    - Change from baseline to Day 27 in PDSS total score
    - Change from baseline to Day 27 in PDQ-39 summary index and the 8 dimension scores
    - Need for rescue and/or additional oral LD/CD IR and/or entacapone during the outpatient period
    - Pharmacokinetics at 2 time points
    Il principale endpoint secondario di efficacia ¿ la percentuale di soggetti con fase "ON" completa (ovvero una risposta "ON" comparabile alla risposta "ON" al trattamento orale standard con LD/CD) all'incirca alle 08:00 e alle 09:00 del giorno 28, come determinato dal soggetto e dal valutatore in cieco separatamente.
    Gli altri endpoint di efficacia secondari sono:
    - Variazione dalla visita basale al giorno 28 nelle fasi quotidiane "ON" senza discinesia e nelle fasi "ON" con discinesia (lieve, moderata, grave) come determinato da un valutatore in cieco, dove le fasi "ON" sono definite come fasi con buona risposta al farmaco e pochi sintomi.
    - Variazione dalla visita basale al giorno 28 nel punteggio UPDRS parte III (capacit¿ motorie), a 4 e 8 ore dopo l'inizio della dose/infusione
    - Variazione nel punteggio UPDRS parte II (ADL) dalla visita basale al giorno 28
    - Punteggio CGI-Improvement (CGI-I) del giorno 28 e la variazione dalla visita basale al giorno 28 nel
    punteggio CGI-Severity (CGI-S) come determinato dallo sperimentatore
    - Cambiamento del punteggio totale del PDSS al giorno 27 rispetto alla visita basale
    - Variazione dalla visita basale al giorno 27 dell'indice sintetico del questionario PDQ-39 e i punteggi sulle 8 dimensioni
    - Necessit¿ di dosi di soccorso e/o dosi supplementari di LD/CD IR e/o di entacapone durante il periodo domiciliare
    - Farmacocinetica in 2 momenti temporali
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 27 and Day 28
    Giorno 27 e giorno 28
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio con medico valutatore in cieco
    Rater-blinded study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Austria
    Germany
    Israel
    Italy
    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 years1
    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 years1
    E.8.9.2In all countries concerned by the trial months2
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 47
    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)
    Subjects would just revert to normal standard of care or will enter in the open label study.
    I pazienti torneranno alla normale pratica clinica, o saranno arruolati nello studio di estensione in aperto.
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
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