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    Summary
    EudraCT Number:2017-004754-42
    Sponsor's Protocol Code Number:PP06490
    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:2021-01-29
    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 number2017-004754-42
    A.3Full title of the trial
    A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in patients with first-line metastatic colorectal cancer
    EN_A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in patients with first-line metastatic colorectal cancer

    IT_Studio di fase 3, in doppio cieco, multicentrico, controllato con placebo, utilizzando PledOx in aggiunta a FOLFOX6 modificato (5-FU/FA e oxaliplatino) per prevenire la neuropatia periferica indotta da chemioterapia (CIPN) in pazienti in prima linea per cancro del colon-retto metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, double-blind, multicenter, placebo-controlled study of a new drug, PledOx used on top of standard therapy to prevent damages to nerves of the peripheral nervous system, induced by chemotherapy, in patients suffering from cancer of the large intestine that have spread to other parts of the body

    Trattamento preventivo della neuropatia periferica indotta da Oxaliplatino nel cancro del colon-retto metastatico
    A.3.2Name or abbreviated title of the trial where available
    POLAR M
    POLAR M
    A.4.1Sponsor's protocol code numberPP06490
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    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 SponsorPLEDPHARMA AB
    B.1.3.4CountrySweden
    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 supportPledPharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPledPharma AB
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressGrev Turegatan, 11c
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE 114 46
    B.5.3.4CountrySweden
    B.5.6E-mailstefan.carlsson@pledpharma.se
    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 namePledOx 50mM
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 1401243-67-1
    D.3.9.2Current sponsor codeCalmangafodipir
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy induced peripheral neuropathy
    Neuropatia periferica indotta da chemioterapia
    E.1.1.1Medical condition in easily understood language
    Damages to nerves of the peripheral nervous system, induced by chemotherapy
    Danno al sistema nervoso periferico, indotto dalla chemioterapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036109
    E.1.2Term Polyneuropathy due to drugs
    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 compare each dose of PledOx (2 and 5 ¿mol/kg) vs placebo with respect to the proportion of patients with moderate or severe chronic CIPN
    Confrontare ciascuna dose di PledOx (2 e 5 ¿mol/kg) con il placebo, tenuto conto della proporzione di pazienti affetti da CIPN cronica moderata o grave.
    E.2.2Secondary objectives of the trial
    To compare each dose of PledOx vs placebo regarding the following:
    Efficacy
    - The proportion of patients with mild, moderate or severe chronic
    CIPN
    - The sensitivity to touching cold items
    - The cumulative dose of oxaliplatin during chemotherapy
    - The vibration sensitivity on the lateral malleolus
    - The worst pain in hands or feet
    - The functional impairment (in the non-dominant hand)
    - The sustained efficacy on prevention of CIPN during long-term
    follow-up
    Safety
    - Overall response rate (ORR)
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - Safety and tolerability
    For exploratory objectives, due to limit of characters, please refer to synopsis
    Confrontare ciascuna dose di PledOx con il placebo in relazione ai seguenti parametri:
    Efficacia
    - La proporzione di pazienti affetti da CIPN cronica leggera, moderata o grave
    - La sensibilit¿ al contatto con oggetti freddi
    - La dose cumulativa di oxaliplatino durante la chemioterapia
    - La sensibilità alle vibrazioni rilevata al malleolo laterale
    - Il dolore più intenso alle mani o ai piedi
    - La compromissione funzionale (nella mano non dominante)
    - L¿efficacia prolungata nella prevenzione della CIPN durante il follow-up a lungo termine
    Sicurezza
    - overall response rate (ORR)
    - Sopravvivenza libera da progressione (PFS)
    - Sopravvivenza globale (OS)
    - Sicurezza e tollerabilità
    Per gli obiettivi esplorativi, per superamento limite dei caratteri disponibili, fare riferimento alla sinossi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Signed informed consent form before any study related assessments and willing to follow all study procedures.
    2. Male or female aged =18 years.
    3. Metastatic (stage IV) CRC, pathologically confirmed adenocarcinoma of the colon or rectum.
    4. No prior chemotherapy (within the previous 12 months) and/or biologic/targeted therapy for mCRC.
    5. Measurable disease according to RECIST 1.1.
    6. Patient indicated for at least 3 months of oxaliplatin-based chemotherapy (without any pre-planned treatment breaks) and without pathological findings of a neurologic exam performed prior to oxaliplatin treatment according to local practice
    7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    8. Adequate hematological parameters: hemoglobin =100 g/L, absolute neutrophil count (ANC) =1.5 x 109/L, platelets =100 x 109/L.
    9. Adequate renal function: creatinine clearance >50 cc/min using the Cockroft and Gault formula or measured.
    10. Adequate hepatic function: total bilirubin =1.5 times the upper limit of normal (ULN) (except in the case of known Gilbert’s syndrome); aspartate aminotransferase (AST) and alanine
    aminotransferase (ALT) =3 times ULN (AST and ALT =5 times ULN in case of liver metastases).
    11. Baseline blood manganese (Mn) level <2.0 times ULN.
    12. For patients with a history of diabetes mellitus, HbA1c =7%.
    13. Negative pregnancy test for females of child-bearing potential.
    14. For men and females of childbearing potential, use of adequate contraception (oral contraceptives, intrauterine device or surgically sterile) while on study drug and for at least 6 months after completion of study therapy.
    Criteri di inclusione
    1. Firma del modulo per il consenso informato prima di eseguire qualsiasi valutazione correlata allo studio e intenzione di seguire tutte le procedure di studio.
    2. Uomo o donna di età uguale o superiore ai 18 anni.
    3. Adenocarcinoma metastatico (allo stadio IV) del colon o del retto (CRC) patologicamente confermato.
    4. Assenza di precedente chemioterapia (durante i 12 mesi precedenti) e/o di terapia biologica/mirata contro l’mCRC.
    5. Patologia misurabile in base alla scala RECIST 1.1.
    6. Paziente con prescrizione di chemioterapia a base di oxaliplatino di almeno 3 mesi (senza interruzioni terapeutiche pianificate) e privo di risultati patologici di un esame neurologico eseguito prima del trattamento con oxaliplatino secondo la pratica locale
    7. Performance status di 0 o 1 in base alla scala ECOG (Eastern Cooperative Oncology Group).
    8. Parametri ematologici adeguati: emoglobina =100 g/l, conta assoluta dei neutrofili (ANC) =1,5 x 109/l, piastrine =100 x 109/l.
    9. Funzione renale adeguata: clearance della creatinina >50 cc/min in base alla formula di Cockcroft-Gault o alla misurazione.
    10. Funzione epatica adeguata: bilirubina totale =1,5 volte il limite superiore della norma (ULN) (eccetto in caso di sindrome di Gilbert acclarata); aspartato aminotrasferasi (AST) e alanina aminotrasferasi (ALT) =3 volte l’ULN (AST e ALT =5 volte l’ULN in caso di metastasi epatiche).
    11. Livello di manganese (Mn) ematico al basale <2,0 volte l’ULN.
    12. Per i pazienti con anamnesi di diabete mellito, HbA1c =7%.
    13. Per le donne potenzialmente fertili, test di gravidanza negativo.
    14. Per le donne e gli uomini potenzialmente fertili, utilizzo di un adeguato metodo anticoncezionale (contraccettivi orali, dispositivo intrauterino o sterilizzazione chirurgica) durante l’assunzione del farmaco in studio e durante almeno i 6 mesi successivi al completamento della terapia di studio.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Any unresolved toxicity by Common Terminology Criteria for Adverse Events Version (CTCAE v4.03) > Grade 1 from previous anti-cancer therapy (including radiotherapy), except alopecia.
    2. Any grade of neuropathy from any cause.
    3. Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, unresolved bowel obstruction, hepatic or renal disease).
    4. Chronic infection or uncontrolled serious illness causing immunodeficiency.
    5. Any history of seizures
    6. A surgical incision that is not healed
    7. Significant hemorrhage (>30 mL/bleeding episode in previous 3 months), hemoptysis (>5 mL fresh blood in previous 4 weeks) or thrombotic event (including transient ischemic attack) in the
    previous 12 months if the patient is expected to receive antivascular endothelial growth factor (VEGF) / vascular endothelial growth factor receptor (VEGFR) therapy
    8. Known hypersensitivity to any of the components of mFOLFOX6 and, if applicable, biological therapies to be used in conjunction with the chemotherapy regimen or any of the excipients of these products
    9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for that other malignancy for at least 2 years
    10. Known dihydropyrimidine dehydrogenase deficiency.
    11. Pre-existing neurodegenerative disease (e.g., Parkinson’s, Alzheimer’s, Huntington’s) or neuromuscular disorder (e.g.,
    multiple sclerosis, amyotrophic lateral sclerosis, polio, hereditary neuromuscular disease).
    12. Major psychiatric disorder (major depression, psychosis), alcohol and/or drug abuse.
    13. Patients with a history of second or third degree atrioventricular block or a family heredity.
    14. A history of a genetic or familial neuropathy.
    15. Treatment with any investigational drug within 30 days prior to randomization.
    16. Pregnancy, lactation or reluctance to using contraception.
    17. Any other condition that, in the opinion of the Investigator, places the patient at undue risk.
    18. Previous exposure to mangafodipir or calmangafodipir.
    19. Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely.
    Criteri di esclusione
    1. Eventuali tossicità non risolte, come definite dai criteri CTCAE v4.03 (Common Terminology Criteria for Adverse Events) superiori al grado 1, scaturite da precedenti terapie anticancro (compresa radioterapia), eccetto l’alopecia.
    2. Qualsiasi grado di neuropatia provocato da qualsiasi causa.
    3. Qualsiasi evidenza di patologia sistemica grave o non controllata (per es., patologie respiratorie, cardiache, epatiche o renali instabili
    o non compensate, occlusione intestinale non risolta).
    4. Infezione cronica o patologie gravi non controllate che provochino immunodeficienza.
    5. Anamnesi di crisi convulsive
    6. Incisione chirurgica non cicatrizzata.
    7. Emorragia significativa (>30 ml per episodio di sanguinamento nei 3 mesi precedenti), emottisi (>5 ml di sangue fresco durante le 4 settimane precedenti) o eventi trombotici (compreso attacco ischemico transitorio) durante i 12 mesi precedenti, qualora si preveda di somministrare al paziente una terapia contro il fattore di crescita dell’endotelio vascolare (VEGF) / il recettore del fattore di crescita dell’endotelio vascolare (VEGFR)
    8. Ipersensibilità nota a uno qualsiasi dei componenti di mFOLFOX6 e, ove applicabile, delle terapie biologiche da utilizzare in concomitanza con il regime chemioterapico o ipersensibilità a uno degli eccipienti dei suddetti prodotti
    9. Anamnesi di altre neoplasie maligne (eccetto in caso di carcinoma a cellule basali o squamose o di carcinoma in situ adeguatamente trattati) durante gli ultimi cinque anni, a meno che il paziente non sia libero dalla suddetta malattia da almeno 2 anni.
    10. Carenza acclarata di diidropirimidina deidrogenasi.
    11. Patologie neurodegenerative preesistenti (per es., morbo di Parkinson, morbo di Alzheimer, morbo di Huntington) o malattie neuromuscolari (per es., sclerosi multipla, sclerosi laterale amiotrofica, poliomelite o malattia neuromuscolare ereditaria).
    12. Disturbi psichiatrici maggiori (depressione maggiore, psicosi), abuso di alcol e/o di droghe.
    13. Pazienti con anamnesi di blocco atrio-ventricolare di secondo o terzo grado o con ereditarietà familiare.
    14. Anamnesi di neuropatia genetica o familiare.
    15. Trattamento con farmaci sperimentali durante i 30 giorni precedenti la randomizzazione.
    16. Gravidanza, allattamento o riluttanza all’utilizzo della contraccezione.
    17. Qualsiasi altra condizione che, secondo il parere dello sperimentatore, esponga il paziente a un rischio eccessivo.
    18. Precedente esposizione al mangafodipir o al calmangafodipir.
    19. Saldatori, minatori o lavoratori occupati (attualmente o in passato) in campi che comportino una probabile esposizione a elevate quantità di manganese.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients (with moderate or severe chronic CIPN)
    scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOGNTX-
    13 (i.e., FACT/GOG-NTX-4), targeting numbness, tingling
    or discomfort in hands and/or feet, 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy).
    Proporzione di pazienti (affetti da CIPN cronica moderata o grave) con punteggio 3 o 4 in almeno uno dei primi 4 item della scala FACT/GOG-NTX-13 (cioè FACT/GOG-NTX-4) relativi a intorpidimento, formicolio o fastidio a mani e/o piedi, 9 mesi dopo la prima dose di IMP (cioè PledOx o placebo somministrati il Giorno 1 del Ciclo 1 della chemioterapia con mFOLFOX6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months after first dose of IMP
    9 mesi dopo la prima dose di IMP
    E.5.2Secondary end point(s)
    Efficacy
    - Proportion of patients (with mild, moderate or severe chronic CIPN) scoring 2, 3, or 4, in at least 1 of the first 4 items of the
    FACT/GOG-NTX-13 (i.e. FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 9 months
    after the first dose of IMP.
    - Mean change from baseline in sensitivity to touching cold items on day 2, Cycle 4 of mFOLFOX6 chemotherapy, as assessed by the
    Cold Sensitivity questionnaire.
    - Mean cumulative dose of oxaliplatin administered per patient during mFOLFOX6 chemotherapy, 9 months after the first dose of
    IMP.
    - Mean change from baseline in vibration sense, on the lateral malleolus (left and right), using a graduated tuning fork, at
    9 months after the first dose of IMP.
    - Mean change from baseline in worst pain in hands or feet in the past week, using a numerical rating scale (NRS), at 9 months after
    the first dose of IMP.
    - Mean change from baseline in the time to complete the grooved Pegboard with the non-dominant hand, at 9 months after the first
    dose of IMP.
    - Proportion of patients scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-13 (i.e. FACT/GOG-NTX-4), targeting
    numbness, tingling or discomfort in hands and/or feet, 12, 15, 18, 21 and 24 months after the first dose of IMP.
    Safety
    - PFS
    - Time to death (OS)
    - Safety and tolerability as assessed by adverse events (AEs), laboratory variables and vital signs
    - Proportion of patients with PledOx toxicities in addition to chemotherapy-related toxicities graded using the NCI-CTCAE v4.03
    Efficacia
    ¿ Proporzione di pazienti (affetti da CIPN cronica leggera, moderata o grave) con punteggio 2, 3 o 4 in almeno uno dei primi 4 item della scala FACT/GOG-NTX-13 (cio¿ FACT/GOG-NTX-4) relativi a intorpidimento, formicolio o fastidio a mani e/o piedi, 9 mesi dopo la prima dose di IMP.
    ¿ Variazione media della sensibilit¿ al contatto con gli oggetti freddi rispetto al basale il Giorno 2 del Ciclo 4 di chemioterapia con mFOLFOX6, misurata in base al questionario Sensibilit¿ al Freddo.
    ¿ Dose cumulativa media di oxaliplatino somministrata per paziente durante la chemioterapia con mFOLFOX6, 9 mesi dopo la prima dose di IMP.
    ¿ Variazione media rispetto al basale della sensibilit¿ alle vibrazioni rilevata al malleolo laterale (destro e sinistro) mediante diapason graduato, 9 mesi dopo la prima dose di IMP.
    ¿ Variazione media rispetto al basale del dolore pi¿ intenso a mani o piedi durante la settimana precedente, misurata mediante scala di valutazione numerica (NRS), 9 mesi dopo la prima dose di IMP.
    ¿ Variazione media rispetto al basale del tempo impiegato per completare il test di destrezza manuale Grooved Pegboard con la mano non dominante, 9 mesi dopo la prima dose di IMP.
    ¿ Proporzione di pazienti con punteggio 3 o 4 in almeno uno dei primi 4 item della scala FACT/GOG-NTX-13 (cio¿ FACT/GOG-NTX-4) relativi a intorpidimento, formicolio o fastidio a mani e/o piedi, 12, 15, 18, 21 e 24 mesi dopo la prima dose di IMP.
    Sicurezza
    ¿ PFS
    ¿ Tempo al decesso (OS)
    ¿ Sicurezza e tollerabilit¿ valutate in base a eventi avversi (AE), variabili di laboratorio e segni vitali.
    Per gli End Point esplorativi, per superamento dei caratteri disponibili, fare riferimento alle sinossi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - FACT/GOG-NTX-13, Grooved pegboard, Grad. Tuning fork, Pain NRS: treatment visits 1-12 (D1 of each Cyc), assessment visits M3, 6, 9, 12,
    15, 18, 21 & 24, EoT (D14 last cycle)
    - AEs: treatment V1-12, assessment visits M3 & 6, EoT
    - PFS & OS: assessment M3, 6, 9, 12, 15, 18, 21 & 24, EoS (OS only)
    - Biochem & Blood Mn: Screen, treatment V1, 4, 8, 12, EoT
    - Hemato, Vital sign, ECOG: Screen, treatment V1-12, M3, 6, 9, 12, 15,
    18, 21 & 24, EoT
    - Cold sensitivity: Screen, treatment V2, 4 & 8
    - QoL/health status: treatment V1, 4, 8 & 12, M9-24
    - Physical exam: Screen, treatment V6, assesment M6-24, EoT
    - MRI of CNS and Blood Mn incl. neuro exam: treatment visits 1-12, M3, EoT
    - ECG: Screen
    - PK patients: PK & ECG: treatment V1, 4 & 8
    - Health eco: treament V1, EoT, M12 & M24
    - FACT/GOG-NTX-13, Grooved pegboard, Grad. Tuning fork, Pain NRS: treat visits V1-12 (D1 of each Cyc), assess visits M3, 6, 9, 12, 15, 18, 21
    & 24, EoT (D14 last cycle)
    - AEs: V1-12, M3 & 6, EoT
    - PFS & OS: M3, 6, 9, 12, 15, 18, 21 & 24, EoS (OS only)
    - CT/MRI scan: Screen, V4, 8, 12, M9-24
    - Disease assessment: V5, 9, M6-24, EoT
    - Biochem: V1, 3, 5, 7, 9, 11, EoT
    - Blood Mn: Screen, V4, 8, 12, EoT
    - Hemato, Vital sign, ECOG: Screen, V1-12, M3, 6, 9, 12, 15, 18, 21 & 24, EoT
    - Cold sensitivity: Screen, V2, 4 & 8 days 1, 2, 3 after IMP infusion
    - QoL/health status: V1, 4, 8 & 12, M9-24
    - Physical exam: Screen, M6-24, EoT
    - MRI of CNS and Blood Mn incl. neuro exam: V1-12, M3, EoT
    - ECG: Screen
    - PK patients: PK & ECG: V1, 4 & 8 (EoT for ECG)
    - HE: V1, M6, 12, 18 & 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Taiwan
    United States
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient reaching End of Study: Overall Survival assessment at approximately month 36 (by telephone or any available medical source)
    Ultimo paziente che raggiunge la fine dello studio. Sopravvivenza a circa 36 mesi (per telefono o qualsiasi altra ricerca medica)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 210
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 420
    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)
    -
    -
    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 Decision2018-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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