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    Summary
    EudraCT Number:2016-001403-23
    Sponsor's Protocol Code Number:M15-535
    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:2021-09-06
    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 number2016-001403-23
    A.3Full title of the trial
    An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative
    interventional trial on Duodopa VERsus oral medication)
    Sperimentazione Randomizzata, In Aperto, della Durata di 12 Settimane per Valutare l’Efficacia di Levodopa-Carbidopa Gel Intestinale/Carbidopa-Levodopa Sospensione Enterale Rispetto al Trattamento Medico Ottimizzato (Optimized Medical Treatment) sulla Discinesia in Soggetti con Malattia di Parkinson in Fase Avanzata DYSCOVER (DYSkinesia Comparative Interventional trial on Duodopa VERsus oral medication).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.
    Sperimentazione della durata di 12 Settimane per valutare l’Efficacia di Levodopa-Carbidopa Gel Intestinale/Carbidopa-Levodopa Sospensione Enterale Rispetto al Trattamento Medico Ottimizzato sulla Discinesia in Soggetti con Malattia di Parkinson in Fase Avanzata.
    A.3.2Name or abbreviated title of the trial where available
    DYSCOVER Study
    Studio DYSCOVER
    A.4.1Sponsor's protocol code numberM15-535
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 Duodopa
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namena
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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 codeN.D.
    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 number20
    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 codeN.D.
    D.3.9.3Other descriptive nameCARBIDOPA MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Dyskinesia in advanced Parkinson's disease
    Discinesia in Soggetti con Malattia di Parkinson in Fase Avanzata
    E.1.1.1Medical condition in easily understood language
    Advanced Parkinson's disease
    Malattia di Parkinson in Fase Avanzata
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this interventional study is to examine the effect of LCIG treatment relative to that of Optimized Medical Treatment (OMT) on dyskinesia as measured by the Unified Dyskinesia Rating Scale (UDysRS) Total Score.
    L’obiettivo primario di questa sperimentazione interventistica è quello di studiare l’effetto del trattamento con LCIG rispetto all’effetto del trattamento medico ottimizzato (OMT) sulla discinesia, misurato in base alla variazione del punteggio totale UDysRS (Unified Dyskinesia Rating Scale).
    E.2.2Secondary objectives of the trial
    The Secondary objective is to assess the effect of LCIG treatment relative to that of OMT on dyskinesia as measured by PD Diaries, motor symptoms, motor complications, safety, tolerability and health-related outcome measures.
    L’obiettivo secondario è quello di valutare gli effetti del trattamento con LCIG rispetto all’effetto del trattamento medico ottimizzato (OMT) sulla discinesia, misurati in base ai Diari della Malattia di Parkinson, sintomi motori e non-motori, complicanze motorie, sicurezza, tollerabilità ed esiti relativi alla salute.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects of at least 30 years old at the time of Visit 3.
    2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
    3. Patients with advanced levodopa-responsive Parkinson's disease and persistent motor fluctuations who have not been controlled with optimized medical treatment. "Optimized medical treatment" is defined
    as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other
    antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
    4. UDysRS Total score = 30 at Visit 3 based on Central Blinded Rater's score.
    5. Subject (or subject's proxy/caregiver) must be able to complete both the Subject Dosing Diary and the PD Diary and must be able to demonstrate the ability to operate, manipulate, and care for the pump and tubing.
    6. Subject must demonstrate at least 75% concordance with the Investigator's or qualified designee's assessment of symptoms on the Parkinson's Disease Diary following training at Screening Visit 1 with concordance on at least 1 time interval of "Off," concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time
    interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.
    7. Subject is eligible to transfer to commercial treatment of Duodopa after completing the study based on local country requirements.
    1.Soggetti di ambo i sessi e di età pari o superiore a 30 anni al momento della Visita 3.
    2.Soggetto con diagnosi di malattia di Parkinson idiopatica secondo i criteri Brain Bank UKPDS (United Kingdom Parkinson’s Diseases Society)
    3.Pazienti con malattia di Parkinson in fase avanzata responsiva alla levodopa, con persistenti fluttuazioni motorie non controllate in maniera adeguata con il trattamento medico ottimizzato. Per “trattamento medico ottimizzato” si intende l’effetto terapeutico massimo ottenuto con le terapie farmacologiche antiparkinson, dove non sia atteso alcun ulteriore miglioramento da qualsiasi ulteriore aggiustamento della levodopa e/o di altri farmaci antiparkinson. Tale valutazione si baserà sul giudizio clinico dello sperimentatore.
    4.Punteggio totale UDysRS = 30 alla Visita 3, secondo il punteggio del Rater centralizzato in cieco.
    5.Soggetto (o rappresentante o caregiver del soggetto) in grado di compilare sia il Diario di Somministrazione per il Soggetto sia il Diario della Malattia di Parkinson e di dimostrare la propria capacità di utilizzare, gestire ed avere cura della pompa per infusione e del sistema di tubi.
    6.Soggetto per cui viene dimostrata, dopo opportuno training alla Visita 1 di Screening, una concordanza di almeno il 75% fra la valutazione dei sintomi, eseguita dallo Sperimentatore o da un suo incaricato qualificato ed il Diario della Malattia di Parkinson; con concordanza riguardo almeno un periodo di “OFF”, almeno un periodo “ON a prescindere dalla discinesia” e almeno un periodo “ON con discinesia”, a prescindere dal grado di disturbo associato alla discinesia.
    7.Soggetto idoneo a passare al trattamento con Duodopa commerciale dopo aver concluso la sperimentazione, nel rispetto della normativa nazionale.
    E.4Principal exclusion criteria
    1. Predominantly di-phasic dyskinesia, as per Investigator discretion.
    2. Patients who were treated with LCIG before
    3. Patients who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation.
    4. A Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 or significant cognitive impairment that, in the opinion of the Investigator, could impact the subject's ability to participate in the trial
    5. Current primary psychiatric diagnosis of uncontrolled acute psychotic disorder or primary psychiatric diagnoses of bipolar disorder, schizophrenia, obsessive compulsive disorder or currently experiencing a major depressive episode with psychotic features per Diagnostic and
    Statistical Manual of Mental Disorders Fifth Edition, Text Revision (DSM-V-TR).
    6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Investigator.
    7. Current diagnosis or history of drug or alcohol abuse (DSM-V-TR criteria) within 12 months prior to screening visit.
    8. Participation in a concurrent interventional or observational study.
    9. Lack of motivation or insufficient language skills to complete the study questionnaires.
    10. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism(e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), atypical Parkinson Syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body
    disease) or other neurodegenerative disease that might mimic the symptoms of PD.
    1.Discinesia prevalentemente bifasica, in base al giudizio dello sperimentatore.
    2.Pazienti trattati in precedenza con LCIG.
    3.Pazienti sottoposti a pregresso intervento chirurgico per la malattia di Parkinson tra cui, a titolo esemplificativo ma non esaustivo, la stimolazione cerebrale profonda (deep brain stimulation, DBS) oppure il trapianto di cellule.
    4.Punteggio alla scala MMSE (Mini-Mental State Examination) < 24 in occasione della Visita 1 oppure significativa compromissione cognitiva che, a giudizio dello Sperimentatore, possa interferire con la capacità del soggetto di partecipare alla sperimentazione
    5.Attuale diagnosi psichiatrica primaria di disturbo psicotico acuto non controllato o diagnosi psichiatrica primaria di sindrome bipolare, schizofrenia, disturbo ossessivo-compulsivo o soggetti che al momento soffrono di un episodio depressivo maggiore con elementi psicotici in base ai criteri Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Text Revision (DMSIV-TR).
    6.Soggetti che presentano colpi di sonno oppure comportamento impulsivo (es., gioco d’azzardo patologico, ipersessualità) considerati clinicamente significativi dallo Sperimentatore, in qualsiasi momento nei tre mesi precedenti le valutazioni dello Screening.
    7.Diagnosi in atto o storia di abuso di stupefacenti o alcolici (in base ai criteri DSM-IV-TR) nei 12 mesi precedenti la visita di screening
    8.Partecipazione simultanea ad una sperimentazione interventistica o ad uno studio osservazionale.
    9.Scarsa motivazione oppure capacità linguistiche insufficienti a completare i questionari previsti dalla sperimentazione
    10.Soggetto la cui diagnosi di Malattia di Parkinson non è chiara o per cui si sospetti una sindrome parkinsoniana quale il parkinsonismo secondario (es., indotto da farmaci, tossine, agenti infettivi, vasculopatia, trauma, neoplasie cerebrali), sindrome parkinsoniana atipica (es, Atrofia Sistemica Multipla, Paralisi Sopranucleare Progressiva, Malattia a Corpi di Lewy Diffusi) o altre patologie neurodegenerative che mimano i sintomi del Parkinson.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score
    Variazione media del punteggio totale UDysRS, rispetto al baseline, rilevato alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    Baseline, Settimana 2, 4, 8, 12/visita di conclusione anticipata
    E.5.2Secondary end point(s)
    Secondary endpoints (with hierarchical analysis)
    • ON time without troublesome dyskinesia as measured by the PD Diary
    • PDQ-8 Summary Index
    • CGI-C
    • UPDRS Part II Score
    • OFF time as measured by PD Diary
    • UPDRS Part III Score
    Additional Efficacy Endpoints are:
    ¿ UDysRS Historical Score, Objective Score and Parts 1 through 4 Scores
    ¿ ON time with troublesome dyskinesia and ON time without dyskinesia
    as measured by PD Diary
    ¿ mAIMS
    Additional Health Outcome Endpoints:
    ¿ King's PD Pain Scale
    Endpoint Secondari (con analisi gerarchica):
    • Durata del periodo ON senza discinesie fastidiose, misurata in base al Diario PD
    • Punteggio PDQ-8 Summary Index
    • Valutazione CGI-C
    • Punteggio UPDRS Parte II
    • Durata del periodo OFF misurata in base al Diario PD
    • Punteggio UPDRS Parte III
    Ulteriori Endpoint di Efficacia:
    • Punteggio Storico UDysRS, Punteggio Obiettivo e Punteggi relativi alle Parti 1, 2, 3 e 4
    • Durata del periodo ON con discinesia fastidiosa e del periodo ON senza discinesie, misurata in base al Diario PD
    • Punteggio mAISM
    Ulteriori Endpoint relativi agli Esiti di Salute:
    • Punteggio King’s PD Pain Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    2. Baseline, Week 8, Week 12/Early termination visit
    3. Week 2, Week 4, Week 8, Week 12/Early termination visit
    4. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    5. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    6. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    7. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    8. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    9. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    10. Baseline, Week 4, Week 8, Week 12/Early termination visit
    1. Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    2. Baseline, Settimana 8, 12/Visita di conclusione Anticipata
    3. Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    4. Screening, Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    5. Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    6. Screening, Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    7. Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    8. Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    9. Baseline, Settimana 2, 4, 8, 12/Visita di conclusione Anticipata
    10. Baseline, Settimana 4, 8, 12/Visita di conclusione Anticipata
    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) 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
    Trattamento Medico Ottimizzato
    Optimized medical treatment
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    United States
    European Union
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    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 randomized to the LCIG treatment arm will be able to continue the treatment via commercial product. Subjects randomized in the OMT arm will be eligible for commercial LCIG/CLES. All commercial treatment will be provided through the local country's commercial program and local insurance reimbursement.
    I soggetti randomizzati nel braccio LCIG avranno la possibilità di continuare il trattamento con il farmaco commerciale. I soggetti randomizzati nel braccio OMT saranno eleggibili a passare al trattamento con il farmaco commerciale LCIG/CLES. Tutti i trattamenti con farmaco commerciale saranno rimborsati seguendo le normali procedure locali.
    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 Decision2016-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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