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    EudraCT Number:2016-003961-25
    Sponsor's Protocol Code Number:TOZ-CL06
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-03-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003961-25
    A.3Full title of the trial
    A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose “Wearing-Off”
    Studio multicentrico, in aperto per la valutazione della sicurezza e della tollerabilità di tozadenant come terapia aggiuntiva in pazienti affetti da malattia di Parkinson trattati con levodopa, che mostrano un effetto di “wearing off”/deterioramento di fine dose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing "wearing off"
    Uno studio per valutare la sicurezza e la tollerabilità di tozadenant nei pazienti affetti da morbo di Parkison, che stanno assumendo levodopa e che mostrano un effetto di "wearing-off"
    A.3.2Name or abbreviated title of the trial where available
    A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are
    Uno studio per valutare la sicurezza e la tollerabilità di tozadenant nei pazienti affetti da morbo
    A.4.1Sponsor's protocol code numberTOZ-CL06
    A.5.4Other Identifiers
    Name:IND NumberNumber:78230
    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 SponsorBIOTIE THERAPIES INC.
    B.1.3.4CountryUnited States
    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 supportBiotie Therapies
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMS Advanced Medical Services
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAm Exerzierplatz
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.4Telephone number004962170095100
    B.5.5Fax number004962170095140
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtozadenant
    D.3.9.1CAS number 870070-55-6
    D.3.9.2Current sponsor codeTOZ
    D.3.9.3Other descriptive nameTOZADENANT
    D.3.9.4EV Substance CodeSUB130095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Parkinson's Disease
    Malattia 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 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations
    Determinare la sicurezza e la tollerabilità di tozadenant in pazienti affetti da MP trattati con levodopa, che mostrano fluttuazioni motorie
    E.2.2Secondary objectives of the trial
    To evaluate the effects of tozadenant on the occurrence of daytime drowsiness, impulsive behavior, and suicidality.
    Determinare gli effetti di tozadenant sulla comparsa di sonnolenza diurna, comportamento impulsivo o suicidalità
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Expanded PK testing - not performed in Europe
    Test PK esteso - non eseguito in Europa
    E.3Principal inclusion criteria
    1. Provide written informed consent.
    2. Patient is considered reliable and capable of adhering to the protocol according to the judgment of the investigator.
    3. Patient has a documented history of idiopathic Parkinson’s disease consistent with the UK Parkinson’s Disease Society Brain Bank Diagnostic criteria prior to the Screening Visit.
    4. Patient has a PD duration of at least 3 years from diagnosis.
    5. Patient has a modified Hoehn and Yahr stage 2–4 when in OFF state (estimated) and ≤ 3 in ON state.
    6. Patient is male or female and 30–80 years old (inclusive) at Screening.
    7. Patient must have a good response to levodopa in the opinion of the investigator, be taking at least four doses of a levodopa-containing medication per day, and at least one other concomitant anti PD medication (dopamine agonists, MAO-B inhibitors, anticholinergic agents, amantadine or entacapone).
    8. Patient is maintained on a regimen of permitted anti-PD medications that has been stable for at least 4 weeks prior to Screening.
    9. Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months and must be currently experiencing end-of-dose “wearing-off” with at least 2.5 hours of OFF time per day as confirmed by a 3-day Baseline diary.
    10. Patient must have achieved the following results for PD diary training, practice diary collection, and Baseline diary recordings:
    a. During a diary concordance session with an approved PD diary trainer/rater (minimum 2.5 hours), patient achieved at least 80% overall diary concordance including at least 1 OFF interval.
    b. Returned a valid 3 day (i.e., 3 consecutive 24 hour periods) practice diary.
    c. Returned valid diary recordings for each of the 3 consecutive days preceding the Baseline Visit that indicated at least 2.5 hours of OFF time on each of the 3 days.
    11. Contraception:
    a. Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 1 month after study completion. Otherwise, women must be postmenopausal (at least 1year absence of vaginal bleeding or spotting, and confirmed by follicle stimulating hormone [FSH] ≥ 40 mIU/mL [or ≥ 40 IU/L] if less than 2 years postmenopausal) or be surgically sterile.
    b. Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation.
    For men and women: Acceptable methods of contraception include use of a condom with spermicide; oral, implantable or injectable contraceptives; intrauterine device (IUD); diaphragm with spermicide; or, diaphragm with condom.
    1. Essere stati informati e aver avuto tempo a sufficienza e l’opportunità di riflettere a proposito della partecipazione e aver fornito il consenso informato scritto
    2. Essere considerati, nel giudizio dello sperimentatore, affidabili e in grado di rispettare il protocollo (per es. in grado di comprendere e compilare i diari), la programmazione delle visite e le istruzioni di somministrazione del farmaco.
    3. Presentare un’anamnesi documentata di malattia di Parkinson idiopatica compatibile con i criteri della UK Parkinson’s Disease Society Brain Bank Diagnostic, prima della visita di screening.
    4. Durata della MP di almeno 3 anni dalla diagnosi.
    5. Stadio Hoehn e Yahr modificato 2–4 quando in stato OFF (stimato) e ≤ 3 quando in stato ON.
    6. Essere uomini o donne di 30–80 anni di età (inclusi) allo screening.
    7. Presentare una buona risposta alla levodopa secondo il parere dello sperimentatore, assumere attualmente almeno quattro dosi al giorno di un farmaco contenente levodopa e almeno un altro farmaco antiparkinsoniano concomitante (agonisti della dopamina, inibitori delle MAO-B, agenti anticolinergici, amantadina o entacapone).
    8. Assumere un regime di farmaci antiparkinsoniani che è rimasto stabile per almeno 4 settimane prima dello screening.
    9. Aver assunto un farmaco antiparkinsoniano contenente levodopa continuativamente per almeno gli ultimi 12 mesi e presentare attualmente un effetto di “wearing off”/deterioramento di fine dose con almeno 2,5 ore di stato OFF al giorno, come confermato da un diario basale di 3 giorni.
    10. Aver conseguito i seguenti risultati per quanto riguarda il training sul diario della MP, la compilazione del diario e le registrazioni del diario al basale:
    a. Durante una sessione di concordanza del diario con un istruttore/valutatore approvato del diario della MP (minimo 2,5 ore), aver raggiunto una concordanza complessiva del diario pari ad almeno l’80% incluso almeno 1 intervallo di stato OFF.
    b. Aver restituito un diario di prova di 3 giorni (ovvero 3 periodi consecutivi di 24 ore) che sia ritenuto valido.
    c. Aver restituito registrazioni valide del diario per ciascuno dei 3 giorni consecutivi precedenti alla visita basale, che abbiano indicato almeno 2,5 ore di stato OFF per ciascuno dei 3 giorni.
    11. Contraccezione:
    a. Le donne potenzialmente fertili devono utilizzare un metodo di contraccezione accettabile* a partire da 4 settimane prima della somministrazione del farmaco dello studio e per almeno 1 mese dopo il completamento dello studio. Altrimenti, le donne devono essere post-menopausali (almeno 1 anno di assenza di emorragia o perdita vaginale confermata da un livello di ormone follicolo stimolante [FSH] ≥ 40 mUI/mL [o ≥ 40 UI/L] se post-menopausali da meno di 2 anni) oppure devono essere state sterilizzate chirurgicamente.
    b. Gli uomini con una partner potenzialmente fertile devono essere stati sottoposti a vasectomia o devono essere disposti a utilizzare un metodo di contraccezione accettabile* per l’intera durata dello studio e per i 3 mesi successivi all’interruzione del farmaco dello studio.
    * Per gli uomini e le donne: i metodi di contraccezione accettabili comprendono l’uso di un preservativo con spermicida; contraccettivi orali, impiantabili o iniettabili; dispositivo intrauterino; diaframma con spermicida; o diaframma con preservativo.
    E.4Principal exclusion criteria
    1. Patient previously participated in any study with tozadenant.
    2. Patient is currently participating in or has participated in another study and received an IMP within 5 half-lives of the IMP.
    3. Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
    4. Body mass index (BMI) greater than 40.
    5. QTcF interval of ≥ 500 msec at Screening (Visit 1) or the patient has an average QTcF interval ≥ 450 msec for males or ≥ 470 msec for females at Baseline (Visit 2).
    6. Known diagnosis of malignant melanoma.
    7. History of neurosurgical intervention for PD, (the placement of deep brain stimulator electrodes 12 months prior to screening is allowed); subjects with DBS must not be experiencing any clinically meaningful side effects related to the procedure, the device, or stimulation.
    8. Grade 2 hypertension (supine systolic BP ≥ 160 or diastolic BP ≥ 100 mmHg), treated or untreated
    9. Patient with a history of hypertensive crisis unless the underlying cause has been removed (e.g. stenting for renal artery stenosis).
    10. Patient has a history of chronic alcohol or drug abuse within the last 2 years.
    11. Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®, within 4 weeks prior to Screening or is likely to require any of these drugs during the study.
    12. Current treatment with antipsychotics; however, quetiapine administered at doses of ≤ 100 mg per day and pimavanserin are permitted if the patient has been on a stable daily dose for at least 4 weeks before Screening. PRN (as needed) dosing is not permitted.
    13. Patient has taken digoxin within 4 weeks prior to Screening or is likely to require digoxin during the study.
    14. Hyperthyroidism or hypothyroidism, unless all of the following conditions are met:
    a. Patient has received a stable dose of thyroid medication for at least 3 months before the Baseline Visit.
    b. TSH concentrations are in the normal range (± 10% as a window either side of the normal range).
    c. Patient is clinically euthyroid.
    15. Any out-of-range laboratory values at Screening that have not been reviewed and documented as not clinically significant by the investigator.
    16. A score of < 26 on the Mini-Mental State Examination, Second Edition (MMSE-II) at the Screening Visit.
    17. Patients with a current episode of major depression. Patients receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks before the Baseline Visit.
    18. Patient has a recent history of suicide attempt (defined as an active, interrupted or aborted attempt within the past 5 years), or reports suicidal ideation in the past 6 months as indicated by a positive response (‘Yes’) to either Question 4 or Question 5 of the C-SSRS performed at the Screening or Baseline Visit.
    19. Patient has evidence of an impulse control disorder (ICD) (i.e., one or more positive modules) according to the Modified Minnesota Impulse Disorders Interview (mMIDI) unless a structured clinical interview performed during Screening confirms that the patient does not have an ICD.
    20. Patient is currently lactating or pregnant or planning to become pregnant during the duration of the study.
    21. Patient has a known hypersensitivity to any components of the IMP or excipients.
    22. Any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history, at Screening or at Baseline that, in the opinion of the investigator, would make the patient unsuitable for the study or put the patient at additional risk or prejudice evaluation of safety and efficacy of the IMP.
    23. Patients with alanine transaminase (ALT) or aspartate transaminase (AST) ≥3x upper limit of normal (ULN), or total bilirubin ≥1.5x ULN, at Screening.
    24. Patients with a history of hepatic dysfunction secondary to viral infection (hepatitis B or C; Epstein Barr virus [EBV]; or cytomegalovirus [CMV]), or a history of diagnosed drug- or alcohol-induced hepatic toxicity or frank hepatitis.
    25. Patients with moderate to severe hepatic or renal impairment.
    26. Patients who have taken strong cytochrome P450 subtype 3A4 (CYP3A4) inhibitors or inducers within 4 weeks prior to Baseline (Visit 2) or who anticipate requiring use of strong CYP3A4 inhibitors or inducers during the study
    1. Pazienti che abbiano già partecipato in passato a uno studio clinico con tozadenant.
    2. Pazienti che stiano attualmente partecipando o abbiano partecipato a un altro studio con un IMP nelle ultime 5 emivite dell’IMP.
    3. Pazienti che presentino qualsiasi forma di parkinsonismo secondario o atipico (per es. indotto da farmaco, post ictus).
    4. Indice di massa corporea (IMC) maggiore di 40.
    5. Pazienti che presentino un intervallo QTcF ≥ 500 msec allo screening oppure un intervallo QTcF medio ≥ 450 msec per gli uomini o ≥ 470 msec per le donne alla visitabasale (Visita 2).
    6. Diagnosi accertata di melanoma maligno.
    7. Anamnesi di intervento neurochirurgico per la MP, fatta eccezione per il posizionamento di elettrodi di stimolazione cerebrale profonda nei 12 mesi precedenti allo screening; i soggetti sottoposti a stimolazione cerebrale profonda non devono manifestare nessun effetto indesiderato clinicamente significativo correlato alla procedura, al dispositivo o alla stimolazione.
    8. Pazienti con ipertensione di grado 2 (PA sistolica in posizione supina ≥ 160 o PA diastolica ≥ 100 mmHg), trattati o non trattati
    9. Pazienti con anamnesi di crisi ipertensiva a meno che la causa sottostante non sia stata eliminata (per es. posizionamento di stent per stenosi dell’arteria renale).
    10. Pazienti con anamnesi di abuso cronico di alcool o droghe negli ultimi 2 anni.
    11. Pazienti che abbiano assunto apomorfina, budipina, istradefillina, tolcapone o DUOPA™/Duodopa® nelle 4 settimane precedenti allo screening o che abbiano probabilità di dover assumere uno qualsiasi di questi farmaci durante lo studio.
    12. Trattamento attuale con antipsicotici; sono però ammesse la quetiapina somministrata a dosi ≤ 100 mg al giorno e la pimavanserina se il paziente ne ha assunto un dose giornaliera stabile per almeno 4 settimane prima dello screening. Non è ammessa la somministrazione al bisogno.
    13. Pazienti che abbiano assunto digossina nelle 4 settimane precedenti allo screening o che abbiano probabilmente necessità di assumere digossina durante lo studio.
    14. Ipertiroidismo o ipotiroidismo, a meno che siano soddisfatte le seguenti condizioni:
    a. Aver assunto una dose stabile di farmaco per la tiroide per almeno 3 mesi prima della visita basale.
    b. Presentare concentrazioni di TSH che rientrano nella norma (± 10% come finestra a ciascun lato dell’intervallo nella norma).
    c. Essere clinicamente eutiroidei.
    15. Qualsiasi valore di laboratorio fuori intervallo allo screening, che non sia stato analizzato e documentato dallo sperimentatore come non clinicamente significativo.
    16. Punteggio < 26 alla seconda edizione del Mini-Mental State Examination (MMSE-II)
    17. Pazienti con un episodio in corso di depressione maggiore. I pazienti trattati per la depressione con antidepressivi potrebbero essere arruolati se ne hanno assunto una dose giornaliera stabile per almeno 8 settimane prima della visita basale.
    18. Pazienti con anamnesi recente di tentativo di suicido (definito come tentativo attivo, interrotto o abbandonato, negli ultimi 5 anni) o segnalazioni di ideazione suicidaria negli ultimi 6 mesi, come indicato da una risposta positiva (“Sì”) alla domanda 4 o alla domanda 5 del questionario C-SSRS somministrato alla visita di screening o basale.
    19. Pazienti con evidenza di disturbo del controllo degli impulsi (DCI) (ovvero uno o più moduli positivi) secondo la Modified Minnesota Impulse Disorders Interview (mMIDI), a meno che un’intervista clinica strutturata condotta durante lo screening non confermi che il paziente non soffre di DCI.
    20. Pazienti che stiano attualmente allattando oppure siano in gravidanza o pianifichino di iniziare una gravidanza durante lo svolgimento dello studio.
    21. Pazienti che mostrino ipersensibilità nota a qualsiasi componente dell’IMP o agli eccipienti.
    22. Qualsiasi altra condizione o risultato anomalo clinicamente significativo durante l’esame fisico o neurologico, nell’anamnesi psichiatrica e medica, allo screening o alla visita basale, che, secondo il parere dello sperimentatore, renderebbe il paziente non idoneo allo studio o lo metterebbe a maggior rischio oppure pregiudicherebbe la valutazione della sicurezza e dell’efficacia dell’IMP.
    23. Pazienti con ALT o AST ≥ 3 volte ULN, (upper limit of normal) oppure bilirubina totale ≥ 1,5 volte l’ULN allo screening.
    24. Pazienti con anamnesi di disfunzione epatica secondaria a infezione virale (epatite B o C; virus di Epstein Barr [EBV];
    o CMV) o anamnesi di tossicità epatica diagnosticata indotta da farmaco o da alcool oppure epatite franca.
    25. Pazienti con compromissione epatica o renale da moderata a grave.
    26. Pazienti che abbiano assunto potenti inibitori o induttori del citocromo P450 sottotipo 3A4 (CYP3A4) nelle 4 settimane precedenti alla visita basale (Visita 2) o che si prevede abbiano necessità di usare potenti inibitori o induttori del citocromo CYP3A4 durante lo svolgimento dello studio
    E.5 End points
    E.5.1Primary end point(s)
    1. Treatment emergent Adverse Events.
    2. Vital signs
    3. ECGs
    4. Clinical Laboratory tests
    5. Physical and neurological examinations
    1. eventi avversi emergenti dal trattamento (TEAEs, treatment-emergent adverse events),
    2. segni vitali
    3. elettrocardiogrammi (ECG)
    4. analisi cliniche di laboratorio.
    5. Esame fisico e neurologico
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment, assumed to be 52 weeks
    52 settimane
    E.5.2Secondary end point(s)
    Epworth Sleepiness Scale ESS
    modified Minnesota Impulse Disorders Interview mMIDI
    Columbia Suicide Severity Rating Scale C-SSRS
    Unified Parkinson’s Disease Rating Scale (UPDRS) Part I - IV
    Clinical Global Impression of Change (CGI-C).
    Patient’s Global Impression of Change (PGI-C).
    Parkinson’s Disease Quality of Life Questionnaire (PDQ-39; total score and individual domain scores).
    Non-motor Symptom Questionnaire.
    EuroQol 5D-5L Health Questionnaire (EQ-5D-5L).
    Patient-completed diaries (Change from Baseline in the number of hours per day spent as follows: OFF time, ON time without troublesome dyskinesia, total ON time, ON time with troublesome dyskinesia and asleep time).
    Healthcare Resource Utilization.
    scala di valutazione della sonnolenza di Epworth (ESS, Epworth Sleepiness Scale)
    Intervista modificata sui disturbi degli impulsi del Minnesota (mMIDI, Modified Minnesota Impulse Disorders Interview)
    Scala di valutazione della gravità del rischio di suicidio della Columbia (C-SSRS, Columbia-Suicide Severity Rating Scale).
    scala unificata di valutazione della malattia di Parkinson (UPDRS, Unified Parkinson’s Disease Rating Scale) parte I - IV
    Impressione globale del cambiamento dal punto di vista del medico (CGI-C, Clinical Global Impression of Change).
    Impressione globale del cambiamento dal punto di vista del paziente (PGI-C, Patient’s Global Impression of Change).
    Questionario di valutazione della qualità della vita con la malattia di Parkinson (Parkinson Disease Quality of Life Questionnaire, PDQ-39;
    Questionario di valutazione dei sintomi non motori.
    Questionario EuroQol 5D-5L di valutazione dello stato di salute (EQ-5D-5L).
    Diari compilati dal paziente (variazione dal basale nel numero di ore al giorno trascorse, come indicato di seguito: tempo in stato OFF, tempo in stato ON senza discinesia problematica, tempo totale in stato ON, tempo in stato ON con discinesia problematica e tempo di sonno).
    Utilizzo delle risorse sanitarie
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment, assumed to be 52 weeks
    52 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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    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
    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 months0
    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 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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 292
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 450
    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)
    Patients will return to standard of care under their neurologists
    I pazienti torneranno agli standard di cura sotto i loro neurologi
    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 Decision2017-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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