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    Summary
    EudraCT Number:2018-003148-21
    Sponsor's Protocol Code Number:BASICstudy
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003148-21
    A.3Full title of the trial
    BASIC - Botulinum toxin type A blockade of the sphenopalatine ganglion in treatment-refractory chronic cluster headache
    BASIC - Blocco del ganglio sfenopalatino mediante tossina botulinica di tipo A nel trattamento della cefalea a grappolo cronica refrattaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin in treatment-refractory chronic cluster headache
    Tossina botulinica di tipo A nel trattamento della cefalea a grappolo cronica refrattaria
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberBASICstudy
    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 SponsorNorwegian University of Science and Technology
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Liaison Committee between the Central Norway Regional Health Authority and NTNU
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNTNU, Norwegian University of Science and Technology
    B.5.2Functional name of contact pointDepartement of Neuromedicine and Mo
    B.5.3 Address:
    B.5.3.1Street AddressEdvard Griegs gate 8
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7491
    B.5.3.4CountryNorway
    B.5.6E-mailkontakt@inb.ntnu.no
    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 BOTOX - 100 UNITA' ALLERGAN POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN PHARMACEUTICALS IRELAND
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBOTOX
    D.3.2Product code [Botox]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbotox
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic cluster headache
    Cefalea a grappolo cronica
    E.1.1.1Medical condition in easily understood language
    Chronic cluster headache
    Cefalea a grappolo cronica
    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 10059133
    E.1.2Term Cluster headache
    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
    determine the effect of treatment with botulinum toxin towards the sphenopalatine ganglion (SPG) in treatment refractory chronic cluster headache using an image-guided surgical
    device (MultiGuide).
    Determinare l'effetto del trattamento del ganglio sfenopalatino (SPG) con tossina botulinica nel trattamento della cefalea a grappolo cronica refrattaria, per mezzo di un dispositivo chirurgico guidato da immagini (MultiGuide).
    E.2.2Secondary objectives of the trial
    safety, feasibility, number of responders, acceptability of treatment, cluster headache attack features (intensity, autonomic symptoms, duration), use of acute medication and quality of life measures.
    sicurezza, fattibilità, numero di responders, accettabilità del trattamento, caratteristiche di attacco di cefalea a grappolo (intensità, sintomi autonomici, durata), uso di farmaci acuti e misure di qualità della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed and written consent.
    2. Male or female 18 years of age and older.
    3. Headache attacks fulfilling the International Classification of Headache Disorders (ICHD) III criteria for chronic cluster headache (CCH) 3.1.2.
    4. Dominant headache laterality with = 80% of cluster headache attacks on one side.
    5. Subject reports = 4 cluster attacks/week on the side of their dominant headache laterality.
    6. The condition is pharmacologically refractory defined as suboptimal effect or intolerable side effects or contraindication for verapamil or lithium or suboccipital steroid injection.
    7. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period.
    8. Subject is able to differentiate concomitant headaches from cluster headache.
    9. In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception.
    10. Ability to understand study procedures and to comply with them for the entire length of the study
    Consenso informato e scritto.
    2. Maschio o femmina, 18-85 anni di età.
    3. Attacchi di cefalea che soddisfano i criteri della Classificazione internazionale delle cefalee (ICHD) III per la cefalea a grappolo cronica (CCH) 3.1.2.
    4. Lateralità dominante della cefalea con almeno l’80% degli attacchi di cefalea a grappolo su un lato.
    5. Almeno 4 attacchi di cefalea a grappolo la settimana sul lato dominante riferiti dal soggetto.
    6. Condizione farmacologicamente refrattaria definita come effetto suboptimale o effetti collaterali intollerabili o controindicazioni all’assunzione di verapamil o litio o all’iniezione suboccipitale di steroidi.
    7. Consenso del soggetto a mantenere i regimi farmacologici preventivi in corso per la cefalea (nessuna variazione di tipo, frequenza o dosaggio) per l'intera durata dello studio.
    8. Capacità del soggetto di distinguere le cefalee concomitanti dalla cefalea a grappolo.
    9. Utilizzo di un sistema contraccettivo ad alta efficacia per un periodo di almeno 4 settimane dopo l’iniezione da parte delle donne in età fertile (WOCBP).
    10. Capacità di comprendere le procedure dello studio e di attenersi ad esse per l’intera durata dello studio.
    E.4Principal exclusion criteria
    1 change in type, dosage or dose frequency of preventive headache medications < 1 months prior to baseline/screening or 5 half-lives, whichever is longer.1
    2. change in type, dosage or dose frequency of preventive headachemedications during the baseline period
    3. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer.
    4. Subject is currently participating or has participated in the last 3 months in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device.
    5. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances.
    6. Abuse of drugs or alcohol, including opioids
    7. Use of opioids for =10 days per month
    8. Treatment with pharmacological substances that may interact with BTA (aminoglycosids, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinestases
    9. WOCBP that do not adhere to the requirements for HEC
    10. Pregnancy or breastfeeding in the study period
    11. Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned injection site that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure.
    12. Facial anomaly or trauma which renders the procedure difficult.2
    13. Subject currently has an active oral or dental abscess or a local infection at the site of
    injection based on present symptoms.
    14. Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required reatment in the past 6 months.
    15. Pat. exhibiting a high degree of comorbidity and/or frailty associated with reduced life
    expectancy or high likelihood of hospitalization, at the discretion of the investigator
    16. Pat. with comorbid psychiatric disorders with psychotic or other symptoms making ompliance with the study protocol difficult, at the discretion of the investigator
    17. Pat.. with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.
    18. Pat. with disorders that are known contraindication for botox treatment, especially neuromuscular disorders such as motorneuron disorders and myasthenic syndromes
    19. Subject has had previous radiofrequency ablation, balloon compression, gamma knife, or chemical denervation ) of the ipsilateral trigeminal ganglion or any branch of the trigeminal nerve.
    20. Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation of the ipsilateral SPG.
    21. Subject has had blocks of short-acting anaesthetics of the ipsilateral SPG in the last 3 months.
    22. Subject has undergone onabotulinumtoxinA injections of the head and/or neck or has had an occipital nerve block in the last 3 months.
    23. Subject has a history of bleeding disorders and in the opinion of the Investigator, may lead to an inability to properly conduct the procedure.
    24. Subject has a history of coagulopathy
    25. Subject is unable to stop antithrombotic medication, eg. anticoagulants and/or antiplatelet therapy, before procedure
    26. Subject has been diagnosed with another trigeminal autonomic cephalalgia or trigeminal neuralgia.
    27. Pat. cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
    28.Pat. is a study centre employee who is directly involved in the study or the relative of such an employee.
    1. Variaz. di tipo, dosaggio o frequenza di assunzione dei regimi farmacologici preventivi per la cefalea meno di 1 mese o 5 emivite prima del periodo di riferimento/screening, a seconda del periodo + lungo
    2. Variaz. di tipo, dosaggio o frequenza di assunzione dei regimi farmacologici preventivi per la cefalea nel periodo di riferimento
    3. Partecipa a uno studio clinico di una nuova entità chimica o medicinal soggetto a prescrizione nei 2 mesi o 5 emivite precedenti la somministrazio del farmaco sperimentale, a seconda del periodo + lungo
    4. Partecipaz. concomitante o nei 3 mesi precedenti, a un altro studio clinico in cui il soggetto sia, sia stato o sarà esposto a un farmaco o dispositivo sperimentale o non sperimentale
    5. Reazioni allergiche o di ipersensibilità a marcaina, lidocaina, xilocaina, adrenalina, qualsiasi tossina botulinica o sostanze simili
    6. Abuso di droghe o alcool, compresi gli oppioidi
    7. Uso di oppioidi per almeno 10 giorni al mese
    8. Trattamento con sostanze farmacologiche che possano interagire con BTA (aminoglicosidi, spectinomicina, bloccanti neuromuscolari, sia agenti depolarizzanti sia non depolarizzanti (derivati della tubocurarina), lincosamidi, polimixine, chinidina, solfato di magne o anticolinesterasici
    9. Inosservanza dei requisiti di contraccezione ad alta efficace da parte delle donne in età fertile
    10. Gravidanza o allattamento nel periodo dello studio.
    11. Intervento di chirurgia facciale nella zona della fossa pterigo-palatine o dello sperone zigomatico-mascellare ipsilaterale al sito di iniezione previsto che, a discrezione dello sperimentatore, possa compromettere la possibilità di condurre corretta la procedura.
    12. Anomalia facciale o trauma che renda difficoltosa la procedura.
    13. Ascesso orale o dentale attivo o infezione locale in corso nel sito dell'iniezione, sulla base dei sintomi presenti
    14. Diagnosi di processi infettivi importanti come osteomielite, o neoplasie facciali maligne primarie o secondarie che siano stati attivi o abbiano richiesto un trattamento nei 6 mesi precedenti
    15. Un elevato grado di comorbidità e/o fragilità associato a una ridotta aspettativa di vita o a un’elevata probabilità di ospedalizzazione, a discrezione dello sperimentatore
    16. Disturbi psichiatrici comorbidi con sintomi psicotici o di altro genere che rendano difficoltoso il rispetto del protocollo di studio da parte del soggetto, a discrezione dello sperimentatore
    17. Malattie infettive o infezioni attive che richiedano speciali misure di controllo dell’infezione, come virus di immunodeficienza umana, tubercolosi, o infezione cronica da epatite B o C
    18. Disturbi che costituiscano controindicazioni note al trattamento con botox, in particolare disturbi neuromuscolari come la malattia del motoneurone e le sindromi miasteniche
    19. Pregressa ablazione con radiofrequenza, compressione con palloncino, chirurgia Gamma Knife o denervazione chimica del ganglio del trigemino ipsilaterale o di qualsiasi ramo del nervo trigemino
    20. Pregressa ablazione con radiofrequenza , compressione con palloncino, chirurgia Gamma Knife o denervazione chimica dell’SPG ipsilaterale
    21. Blocchi anestetici a breve durata d’azione dell’SPG ipsilaterale nei 3 mesi preced.
    22. Iniezioni di onabotulino tossina A nella testa e/o nel collo o blocco del nervo occipitale nei 3 mesi preced.
    23. Anamnesi di disturbi emorragici che, a discrezione dello sperimentatore, potrebbero compromettere la possibilità di condurre correttamente la procedura
    24. Anamnesi di coagulopatia
    25. Impossibilità di interrompere una terapia antitrombotica, per esempio anticoagulanti e/o terapia antipiastrinica, prima della procedura
    26. Diagnosi di altra cefalalgia autonomica trigeminale o nevralgia del trigemino.
    27. Impossibilità di partecipare o completare con successo lo studio, per uno dei seguenti motivi
    28. paziente è un dipendente presso la sede dello studio ed è direttamente coinvolto nello studio stesso, o è parente di tale dipendente
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in number of cluster headache attacks per week (as recommended in Guidelines for controlled trials of drugs in cluster headache) during weeks 5 – 8 post intervention in the active group versus the placebo group.
    Variazione del numero di attacchi di cefalea a grappolo la settimana rispetto al riferimento (come raccomandato nelle Linee guida per la sperimentazione controllata di farmaci per la cefalea a grappolo) durante le settimane 5-8 post-intervento nel gruppo attivo rispetto al gruppo placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After unblinding at study end.
    dopo l'unblinding alla fine dello studio
    E.5.2Secondary end point(s)
    1. Number of therapeutic responders (= 50% reduction in attack frequency, intensity or both during weeks 5 – 8 post-intervention compared to baseline).
    2. Number of attack frequency responders (= 50% reduction in attack frequency during weeks
    5 – 8 post-intervention compared to baseline)
    3. Mean attack intensity (10-point numerical response scale - NRS) week 5 – 8 post intervention compared to baseline in the active group versus the placebo group.
    4. Number of days with cluster headache
    5. Patient Global Impression of Improvement.
    6. Quality of life measures (EQ-5D-5L)
    7. Mean attack duration
    8. Number of attacks requiring use of rescue medication (both triptans and oxygen)
    9. Number of responders using concomitant CGRP antagonists versus number of responders
    not using concomitant CGRP antagonists
    10. Autonomic symptoms (most prominent autonomic symptom)
    11. Number of AEs and SAEs in the placebo group versus the verum group
    12. Number of days with headache
    13. Time from injection to onset of effect
    14. Acceptability of treatment
    1. Numero di responder alla terapia (= 50% di riduzione della frequenza o dell’intensità degli attacchi o di entrambe durante le settimane 5-8 post-intervento rispetto al riferimento).
    2. Numero di responder per frequenza degli attacchi (= 50% di riduzione della frequenza degli attacchi durante le settimane 5-8 post-intervento rispetto al riferimento).
    3. Intensità media degli attacchi (scala numerica di risposta - SNR - su base 10) nelle settimane 5-8 post-intervento rispetto al riferimento nel gruppo attivo vs. gruppo placebo.
    4. Numero di giorni con cefalea a grappolo.
    5. Impressione globale di miglioramento del paziente.
    6. Misure di qualità della vita (EQ-5D-5L).
    7. Durata media dell’attacco.
    8. Numero di attacchi che richiedono l'uso di farmaci di soccorso (sia triptani che ossigeno).
    9. Numero di responder che utilizzano antagonisti CGRP concomitanti rispetto al numero di responder che non utilizzano antagonisti CGRP concomitanti.
    10. Sintomi autonomici (sintomo autonomico più evidente).
    11. Numero di AE e SAE nel gruppo placebo rispetto al gruppo verum.
    12. Numero di giorni con cefalea.
    13. Tempo dall'iniezione all'inizio dell'effetto.
    14. Accettabilità del trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After unblinding at study end.
    dopo l'unblinding alla fine dello studio
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    If positive trial subjects may be offered to continue this treatment. Thiswill be up to the local investigators to decide, based on local practice.
    se il trial èpositivo puo essere offerto ai soggetti di continuare il trattamento.Spetta agli investigatori locali decidere, sulla base della pratica locale.
    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 Decision2019-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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