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    Summary
    EudraCT Number:2019-004497-25
    Sponsor's Protocol Code Number:18898A
    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:2021-06-14
    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 number2019-004497-25
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study with an extension period to evaluate the efficacy and safety of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments
    Studio controllato con placebo, interventistico, randomizzato, in doppio cieco, a gruppi paralleli, con un periodo di estensione per valutare l’efficacia e la sicurezza di eptinezumab per la prevenzione dell’emicrania in pazienti con precedenti trattamenti preventivi che non hanno avuto successo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients That Are Not Helped by Previous Preventive Treatments
    Uno studio per valuatare l'efficacia e la sicurezza di eptinezumab per la prevenzione dell'emicrania in pazienti che non sono stati aiutati da precedenti trattamenti preventivi
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number18898A
    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 SponsorH. LUNDBECK A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4536301311
    B.5.5Fax number+4536301940
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 nameEptinezumab
    D.3.2Product code [ALD403, Lu AG09221]
    D.3.4Pharmaceutical form Concentrate for 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 INNEPTINEZUMAB
    D.3.9.1CAS number 1644539-04-7
    D.3.9.2Current sponsor codeLu AG09221
    D.3.9.4EV Substance CodeSUB188646
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 nameEptinezumab
    D.3.2Product code [ALD403, Lu AG09221]
    D.3.4Pharmaceutical form Concentrate for 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 INNEPTINEZUMAB
    D.3.9.1CAS number 1644539-04-7
    D.3.9.2Current sponsor codeLu AG09221
    D.3.9.4EV Substance CodeSUB188646
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Migraine in patients with unsuccessful prior preventive treatments
    Emicrania in pazienti con precedenti trattamenti preventivi che non hanno avuto successo
    E.1.1.1Medical condition in easily understood language
    Migraine
    Emicrania
    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 10027599
    E.1.2Term Migraine
    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
    Evaluation of eptinezumab in the prevention of migraine in patients with unsuccessful prior preventive treatments
    To evaluate the efficacy of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments
    Valutazione di eptinezumab nella prevenzione dell'emicrania nei pazienti con precedenti trattamenti preventivi che non hanno avuto successo
    Valutare l'efficacia di eptinezumab per la prevenzione dell’emicrania nei pazienti con precedenti trattamenti preventivi che non hanno avuto successo
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
    • The patient has a migraine onset of <=50 years of age.
    • The patient has >=4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
    • The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days prior to randomization
    • The patient fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
    • For patients with CM: Migraine occurring on >=8 days and headache occurring on >14 days
    • For patients with EM: Migraine occurring on >=4 days and headache occurring on <=14 days
    • The patient has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
    • The patient has a history of either previous or active use of triptans for migraine.
    Other inclusion criteria may apply
    • Il paziente presenta una diagnosi di emicrania, con un’anamnesi di emicrania cronica o episodica di almeno 12 mesi prima della visita di screening.
    • Il paziente presenta insorgenza di emicrania a <=50 anni di età.
    • Il paziente presenta >=4 giorni mensili con emicrania per ogni mese negli ultimi 3 mesi prima della Visita di screening.
    • Il paziente ha dimostrato conformità al diario elettronico per il mal di testa inserendo i dati per almeno 24 dei 28 giorni prima della randomizzazione
    • Il paziente soddisfa i seguenti criteri per emicrania cronica (CM) o emicrania episodica (EM), in base alle informazioni raccolte in maniera prospettica nel diario elettronico durante il periodo di screening:
    • Per i pazienti con CM: Emicrania manifestata per >=8 giorni e mal di testa manifestato per >14 giorni
    • Per i pazienti con EM: Emicrania manifestata per >=4 giorni e mal di testa manifestato per <=14 giorni
    • Il paziente presenta evidenza documentata di fallimento del trattamento (deve essere supportato dalla cartella clinica o dalla conferma del medico specifica per ciascun trattamento) negli ultimi 10 anni con 2-4 diversi farmaci per la prevenzione dell'emicrania.
    • Il paziente presenta un’anamnesi di uso precedente o attivo di triptani per l’emicrania.
    Possono essere applicati altri criteri di inclusione
    E.4Principal exclusion criteria
    • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
    • The patient has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
    • The patient has confounding and clinically significant pain syndromes, (e.g., fibromyalgia, chronic low back pain, complex regional pain syndrome).
    • The patient has a diagnosis of acute or active temporomandibular disorder.
    • The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
    • The patient has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit.
    Patients with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
    • The patient has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
    Other exclusion criteria may apply
    • Il paziente ha manifestato fallimento di un precedente trattamento mirato al pathway del peptide correlato al gene della calcitonina (calcitonin gene-related peptide, CGRP).
    • Il paziente ha manifestato un fallimento del trattamento con valproato/divalproex o tossina botulinica A/B e il trattamento non è l’ultimo farmaco preventivo prima dell'inclusione nello studio. Il farmaco è considerato l’ultimo se le date di inizio e di interruzione del trattamento sono successive rispetto alle rispettive date di inizio e di interruzione degli altri farmaci preventivi.
    • Il paziente presenta sindromi dolorose confondenti e clinicamente significative (ad es., fibromialgia, lombalgia cronica, sindrome da dolore regionale complesso).
    • Il paziente presenta una diagnosi di disturbo temporo-mandibolare attivo o acuto.
    • Il paziente presenta un’anamnesi o una diagnosi di mal di testa cronico di tipo tensivo, mal di testa ipnico, mal di testa a grappolo, emicrania continua, nuovo mal di testa persistente quotidiano o sottotipi insoliti di emicrania quali emicrania emiplegica (sporadica e familiare), emicrania oftalmica ed emicrania con sintomi neurologici non tipici dell’emicrania con aura (diplopia, alterazione dello stato di coscienza o di lunga durata).
    • Il paziente presenta una condizione psichiatrica non controllata e/o non trattata per un minimo di 6 mesi prima della Visita di screening. Sono esclusi i pazienti con anamnesi di psicosi nel corso della vita e/o di mania negli ultimi 5 anni precedenti alla visita di screening.
    • Il paziente presenta un’anamnesi di malattia cardiovascolare clinicamente significativa o ischemia vascolare o eventi tromboembolici (ad esempio, ictus cerebrovascolari, trombosi venosa profonda o embolia polmonare).
    Possono essere applicati altri criteri di esclusione
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in the number of monthly migraine days
    1. Variazione rispetto al basale del numero di giorni mensili con emicrania
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. [Time Frame: From Baseline to Weeks 1-12]
    1. [Periodo di tempo: dal basale alle settimane 1-12]
    E.5.2Secondary end point(s)
    2. Response: patients with 50% reduction from baseline in monthly migraine days
    3. Change from baseline in the number of monthly migraine days
    4. Response: patients with 75% reduction from baseline in monthly migraine days
    5. Response: patients with 100% reduction from baseline in monthly migraine days
    6. Response: patients with 50% reduction from baseline in monthly headache days
    7. Response: patients with 75% reduction from baseline in monthly headache days
    8. Response: patients with 100% reduction from baseline in monthly headache days
    9. Change from baseline in the number of monthly headache days
    10. Migraine/headaches with severe pain intensity
    11. Change from baseline in the number of monthly migraine days with use of acute medication
    12. Patient Global Impression of Change (PGIC) score
    The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1
    (very much improved) to 7 (very much worse)
    13. Change from baseline in the number of monthly migraine days in patients with Medication Overuse Headache (MOH)
    14. Number of Patients with a migraine on the day after first dosing
    15. Change in Most Bothersome Symptom (MBS) score
    Patients will identify a migraine-related symptom that is most bothersome for them. Patients will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity with sound
    16. Change from baseline in the Headache Impact Test (HIT-6) score
    17. Change from baseline in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores
    Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
    18. Change from baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
    19. Change from baseline in Health Care Resources Utilisation (HCRU) score
    20. Change from baseline in work productivity as measured using the Work Productivity and Activity Impairment Questionnaire (WPAI) subscores
    Sub-scores: (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
    2. Risposta: pazienti con riduzione del 50% rispetto al basale dei giorni mensili con emicrania
    3. Variazione rispetto al basale del numero di giorni mensili con emicrania
    4. Risposta: pazienti con riduzione del 75% rispetto al basale dei giorni mensili con emicrania
    5. Risposta: pazienti con riduzione del 100% rispetto al basale dei giorni mensili con emicrania
    6. Risposta: pazienti con riduzione del 50% rispetto al basale dei giorni mensili con mal di testa
    7. Risposta: pazienti con riduzione del 75% rispetto al basale dei giorni mensili con mal di testa
    8. Risposta: pazienti con riduzione del 100% rispetto al basale dei giorni mensili con mal di testa
    9. Variazione rispetto al basale del numero di giorni mensili con mal di testa
    10. Emicrania/mal di testa con dolore di grave intensità
    11. Variazione rispetto al basale del numero di giorni mensili con emicrania con uso di farmaci per episodi di emicrania acuta
    12. Impressione globale del cambiamento per il paziente (Patient Global Impression of Change, PGIC)
    La PGIC è una misura riportata dal paziente di miglioramento nella sensazione del dolore e qualità di vita segnata su una scala da 1 (molto migliorata) a 7 (molto peggio)
    13. Variazione rispetto al basale del numero di giorni mensili con emicrania in pazienti con mal di testa da abuso di farmaci (Medication Overuse Headache, MOH)
    14. Numero di pazienti con emicrania il giorno successivo alla prima dose
    15. Variazione nel punteggio del Questionario del sintomo più fastidioso (Most Bothersome Symptom, MBS)
    I pazienti identificheranno un sintomo correlato all’emicrania che è più fastidioso per loro. Ai pazienti sarà chiesto di valutare il miglioramento di questo sintomo dallo screening su una scala a 7 punti. Gli elementi fastidiosi pre-specificati sono: nausea, vomito, sensibilità alla luce, sensibilità al suono
    16. Variazione dal basale del punteggio dell’Headache Impact Test (HIT-6)
    17. Variazione dal basale dei punteggi secondari del Questionario sulla qualità della vita specifico per pazienti emicranici (Migraine-Specific Quality of life, MSQ) v2.1
    Punteggi secondari: Restrittivo [Role Function- Restrictive], Preventivo [Role Function-Preventive]; Emotivo [Emotional Function])
    18. Variazione dal basale del punteggio della Scala analogico-visiva (Visual Analogue Scale, VAS) del Questionario europeo sulla qualità della vita a 5 dimensioni e 5 livelli (European quality of life 5 dimensions 5 levels, EQ-5D-5L) correlata alla salute
    19. Variazione dal basale del punteggio sull’Utilizzo delle risorse sanitarie (Health Care Resources Utilization, HCRU)
    20. Variazione dal basale nella produttività lavorativa come misurato utilizzando i punteggi secondari del Questionario sulla compromissione della produttività lavorativa e delle attività (Work Productivity and Activity Impairment Questionnaire, WPAI)
    Punteggi secondari: (assenteismo, presenteeismo, perdita di produttività lavorativa, compromissione dell'attività)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    3. [Time Frame: From Baseline to Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    4. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24, Weeks 25-36, Weeks 37-48, Weeks 49-60, Weeks 61-72]
    5, 6, 7, 8, 9, 10, 13, 15. [Time Frame: From Baseline to Weeks 1-12]
    11. [Time Frame: From Baseline to Weeks 1-12, Weeks 13-24]
    12. [Time Frame: At Week 12 and at Week 24]
    14. [Time Frame: On the day after first dosing]
    16. [Time Frame: From Baseline to Week 12 and from baseline to Week 24, at Weeks 36, 48, 60, and 72]
    17, 18, 19, 20. [Time Frame: From Baseline to Week 12, from Baseline to Week 24]
    2. [Periodo di tempo: dal basale alle settimane 1-12, sett. 13-24, sett. 25-36, sett. 37-48, sett. 49-60, sett. 61-72]
    3. [Periodo di tempo: dal basale alle settimane 13-24, sett. 25-36, sett. 37-48, sett. 49-60, sett. 61-72]
    4. [Periodo di tempo: dal basale alle settimane 1-12, sett. 13-24, sett. 25-36, sett. 37-48, sett. 49-60, sett. 61-72]
    5, 6, 7, 8, 9, 10, 13, 15. [Periodo di tempo: dal basale alle sett. 1-12]
    11. [Periodo di tempo: dal basale alle sett. 1-12, sett. 13-24]
    12. [Periodo di tempo: alla sett. 12 e alla sett. 24]
    14. [Periodo di tempo: il giorno successivo alla prima dose]
    16. [Periodo di tempo: dal basale alla sett. 12 e dal basale alla sett. 24, alla sett. 36, 48, 60, e 72]
    17, 18, 19, 20. [Periodo di tempo: dal basale alla sett. 12, dal basale alla sett. 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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Georgia
    Russian Federation
    United States
    Belgium
    Bulgaria
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Spain
    Sweden
    United Kingdom
    Czechia
    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
    The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.
    La fine complessiva dello studio è definita come l'ultimo contatto specificato dal protocollo con l'ultimo paziente in corso nello studio.
    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 months10
    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 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: 715
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 710
    F.4.2.2In the whole clinical trial 840
    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 in the study will have access to appropriate medical care after they complete or withdraw from the study.
    I pazienti nello studio avranno accesso a cure mediche appropriate dopo aver completato o essersi ritirati dallo studio.
    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 Decision2020-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
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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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