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    Summary
    EudraCT Number:2018-001209-95
    Sponsor's Protocol Code Number:IN18001
    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:2021-08-03
    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 number2018-001209-95
    A.3Full title of the trial
    An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease
    Studio di fase II in aperto volto a valutare la farmacocinetica di Accordion Pill¿ carbidopa/levodopa rispetto a carbidopa/levodopa a rilascio immediato in pazienti affetti da malattia di Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease
    Studio di fase II in aperto volto a valutare la farmacocinetica di Accordion Pill¿ carbidopa/levodopa rispetto a carbidopa/levodopa a rilascio immediato in pazienti affetti da malattia di Parkinson
    A.3.2Name or abbreviated title of the trial where available
    IN 18001
    IN 18001
    A.4.1Sponsor's protocol code numberIN18001
    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 SponsorINTEC PHARMA LTD
    B.1.3.4CountryIsrael
    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 supportIntec Pharma Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntec Pharma Ltd
    B.5.2Functional name of contact pointChief Financial Officer
    B.5.3 Address:
    B.5.3.1Street Address12 HARTOM STREET
    B.5.3.2Town/ cityJERUSALEM
    B.5.3.3Post code9777512
    B.5.3.4CountryIsrael
    B.5.4Telephone number97225864657
    B.5.5Fax number972774701797
    B.5.6E-mailNir@Intecpharma.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 nameAccordion Pill¿ Carbidopa/levodopa
    D.3.2Product code N.A.
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI
    D.2.1.1.2Name of the Marketing Authorisation holderMSD ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSinemet
    D.3.2Product code N.A.
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeLevodopa
    D.3.9.3Other descriptive nameLevodopa
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive name CARBIDOPA
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's Disease (PD)
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease (PD)
    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 PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    To assess the pharmacokinetics of the Accordion Pill¿ carbidopa/levodopa (AP-CD/LD) administered at 500 mg TID compared to immediate release CD/LD administered as 1.5 tablets of Sinemet¿ 25-100 five times per day in Parkinson¿s disease (PD) patients.
    Valutare la farmacocinetica di Accordion Pill¿ carbidopa/levodopa (AP-CD/LD) somministrata alla dose di 500 mg tre volte al giorno (Teris in Die, TID) rispetto a CD/LD a rilascio immediato (IR CD/LD) somministrata sotto forma di 1,5 compresse di Sinemet¿ 25-100 cinque volte al giorno in pazienti affetti da malattia di Parkinson (Parkinson's Disease, PD)
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of AP-CD/LD
    Valutare la sicurezza e la tollerabilit¿ di AP-CD/LD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women 30 years of age or older at screening
    2. Diagnosis of Parkinson’s disease consistent with the UK Brain Bank Criteria
    3. Stable doses of levodopa/carbidopa IR for at least 4 weeks prior to entry
    4. Taking at least 4 doses of immediate release levodopa during waking hours
    5. Taking a total levodopa daily dose of at least 400 mg prior to initial screening assessment
    6. All anti-PD medications are permitted during the study but must be maintained on stable doses for at least 30 days prior to study entry (screening visit). COMT inhibitors will be held prior to PK studies on Day 1 and through Day 8.
    7. Other than PD, the subject is in satisfactory health in the judgment of the investigator. No clinically significant medical, psychiatric or laboratory abnormality that could compromise safety or interfere with study procedures
    8. Subjects must be approved for suitability by an Enrollment Authorization Committee.
    9. Able and willing to give written (signed and dated) informed consent, and to comply with study requirements
    1. Uomini o donne di età pari o superiore a 30 anni allo screening;
    2. Diagnosi di malattia di Parkinson secondo i criteri della UK Brain Bank;
    3. Dosi stabili di levodopa/carbidopa IR per almeno 4 settimane prima dell'ingresso nello studio;
    4. Assunzione di almeno 4 dosi di levodopa a rilascio immediato durante le ore di veglia;
    5. Assunzione di una dose totale giornaliera di levodopa pari ad almeno 400 mg prima della valutazione di screening iniziale;
    6. Durante lo studio sono ammessi tutti i farmaci anti-Parkinson, ma devono essere mantenuti a dosi stabili per almeno 30 giorni prima dell'ingresso nello studio (visita di screening). L'assunzione di inibitori delle COMT sarà sospesa prima degli studi di farmacocinetica eseguiti il Giorno 1 e fino al Giorno 8;
    7. Eccetto per la PD, il soggetto è in uno stato di salute soddisfacente secondo il parere dello sperimentatore. Non presenta alcuna anomalia medica, psichiatrica o di laboratorio clinicamente significativa che potrebbe compromettere la sicurezza o interferire con le procedure dello studio;
    8. I soggetti devono essere approvati ai fini dell'idoneità da parte di un Comitato di autorizzazione all'arruolamento;
    9. Capacità e volontà di fornire il consenso informato scritto (firmato e datato) e di rispettare i requisiti dello studio.
    E.4Principal exclusion criteria
    1. Atypical or secondary parkinsonism
    2. Clinically significant cardiac, pulmonary, hepatic or renal disease or other condition which contraindicates his/her participation in judgment of the investigator or the EAC
    3. Severe dyskinesia as assessed by the PI or the Enrollment Authorization Committee
    4. Significant cognitive impairment in the opinion of the Investigator.
    5. Clinically significant psychiatric illness in the opinion of the Investigator, including psychotic attacks or major depression
    6. Subjects with a history of suicide attempt (including an active attempt, interrupted attempt or aborted attempt) within the last 5 years.
    7. Treatment within the past 28 days with a neuroleptic drug (antipsychotic) or any other drug with anti-dopaminergic properties (e.g. metoclopramide).
    8. Currently experiencing or any known history of psychosis within the previous 2 years.
    9. History of small bowel or gastric surgery (Including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn’s disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis. (Previous appendectomy or hernioplasty will be not be exclusionary)
    10. History of GI pathology of clinical significance as determined by the Investigator.
    11. Regular use of opioids (Intermittent opioid use is not exclusionary)
    12. Allergy to the study drug or any of its excipients or to Yellow Dye #5 (tartrazine)
    13. History of drug or alcohol abuse within past 12 months
    14. Use of an experimental drug within 30 days or five half-lives of screening
    15. Unable to swallow large pills (e.g., large vitamin pills)
    16. Active gastroesophageal reflux (GERD) and regular use of proton pump inhibitors (PPIs)
    17. Women who are pregnant or nursing and women of childbearing potential (defined as from menarche and until becoming post-menopausal unless permanently sterile) who are not willing to use a highly effective method of contraception. Medically acceptable methods of contraception that may be used by the subject and/or partner include:
    • True abstinence when this is in line with the preferred and usual lifestyle of the subject,
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
    o oral
    o intravaginal
    o transdermal (e.g., Ortho Evra),
    • Progestogen-only hormonal contraception associated with inhibition of ovulation
    o oral
    o injectable (e.g., Dep-Provera),
    o implantable (e.g., Norplant),
    • intrauterine device (IUD),
    • surgical sterilization (>6 months),
    • Vasectomized partner (>6 months)
    • Postmenopausal female (no menstrual period for > 2years)
    Hormonal contraceptive therapy must be at a stable dose for at least 90 days prior to first study drug administration. The current contraceptive therapy must be maintained through the end of the study (Safety Follow Up Visit or Early Termination Visit).
    18. History of Narrow-angle Glaucoma.
    19. History of Melanoma or suspicious skin lesion which could be a Melanoma.
    20. Treatment with non-selective monoamine oxidase (MAO) inhibitors during the last 28 days prior to initial screening assessment or planning to take during study participation.
    1. Parkinsonismo atipico o secondario;
    2. Malattia cardiaca, polmonare, epatica o renale clinicamente significativa o altra condizione che, secondo il parere dello sperimentatore o dell'EAC, controindica la partecipazione del soggetto allo studio;
    3. Discinesia grave secondo la valutazione dello sperimentatore principale o dell'EAC;
    4. Deficit cognitivo significativo secondo il parere dello sperimentatore;
    5. Malattia psichiatrica clinicamente significativa secondo il parere dello sperimentatore, inclusi attacchi psicotici o depressione maggiore;
    6. Soggetti con anamnesi di tentato suicidio (ivi inclusi tentativo attivo, tentativo interrotto o tentativoo annullato) negli ultimi 5 anni;
    7. Trattamento negli ultimi 28 giorni con un farmaco neurolettico (antipsicotico) o con qualsiasi altro farmaco con proprietà anti-dopaminergiche (ad es. metoclopramide);
    8. Psicosi corrente o anamnesi nota di psicosi nei 2 anni precedenti;
    9. Anamnesi di intervento chirurgico gastrico e all'intestino tenue (incluso il posizionamento di una sonda PEG-J per duopa/duodopa) o ostruzione intestinale, diagnosi di restringimento dell'intestino tenue, diagnosi di malattia di Crohn, nausea o e mesi frequenti indipendentemente dall'eziologia, e gastroparesi sintomatica (un'appendicectomia o ernioplastica precedente non costituirà un criterio di esclusione);
    10. Anamnesi di patologia gastrointestinale clinicamente significativa, come determinato dallo sperimentatore;
    11. Uso regolare di oppioidi (l'uso intermittente di oppioidi non costituisce un criterio di esclusione);
    12. Allergia al farmaco in studio o a uno qualsiasi dei suoi eccipienti o al colorante giallo n. 5 (tartrazina);
    13. Anamnesi di abuso di droghe o alcol negli ultimi 12 mesi;
    14. Uso di un farmaco sperimentale entro 30 giorni o cinque emivite prima dello screening;
    15. Incapacità di ingerire pillole di grandi dimensioni (ad es. pillole vitaminiche grandi);
    16. Reflusso gastroesofageo (Gastroesophageal Reflux Disease, GERD) attivo e uso regolare di inibitori della pompa protonica (IPP);
    17. Donne in gravidanza o in allattamento e donne potenzialmente fertili (così definite a partire dal menarca sino alla post-menopausa, a meno che non siano permanentemente sterili) non disposte a utilizzare un metodo contraccettivo altamente efficace. Tra i metodi contraccettivi accettabili sotto il profilo medico che possono essere usati dal soggetto e/o dal partner si annoverano:
    • Completa astinenza, se è in linea con lo stile di vita preferito e consueto del soggetto
    • Contraccettivi ormonali combinati (a base di estrogeni e progesterone) associati all’inibizione dell’ovulazione
    o orali
    o intravaginali
    o transdermici (ad es. Ortho Evra)
    • Contraccettivi ormonali a base di solo progesterone associati all’inibizione dell’ovulazione
    o orali
    o iniettabili (ad es. Depo-Provera)
    o impiantabili (ad es. Norplant)
    • Dispositivo intrauterino (IUD)
    • Sterilizzazione chirurgica (>6 mesi)
    • Partner sottoposto a vasectomia (>6 mesi)
    • Donne in post-menopausa (assenza di mestruazioni da >2 anni)
    La terapia contraccettiva ormonale deve essere stata assunta a dose stabile per almeno 90 giorni prima della prima somministrazione del farmaco in studio. La terapia contraccettiva in corso deve essere portata avanti sino alla fine dello studio (visita di follow-up di sicurezza o visita di interruzione anticipata).
    18. Anamnesi di glaucoma ad angolo stretto.
    19. Anamnesi di melanoma o sospetta lesione cutanea che potrebbe essere un melanoma.
    20. Trattamento con inibitori non selettivi delle monoamino ossidasi (MAO) nei 28 giorni precedenti alla valutazione di screening iniziale o previsione di assumere tale trattamento nel corso della partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Variability in plasma levodopa concentration as assessed by the levodopa fluctuation index (fluctuation index = (Cmax-Cmin)/Caverage) (comparison of AP-CD/LD to IR-CD/LD).
    Variabilità della concentrazione plasmatica di levodopa
    in base alla valutazione dell'indice di fluttuazione della
    levodopa (indice di fluttuazione = [Cmax-Cmin]/Cmedia)
    (confronto tra AP-CD/LD e IR-CD/LD).
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK blood sampling will be performed at time 0 and every 30 minutes for 16 hours (from approximately 8:00 AM until midnight) and again at 24 hours on Days 1 and 8.
    Prelievi per le analisi di farmacocinetica saranno effettuati nel Giorno 1 e 8 al tempo 0 e ogni 30 minuti per 16 ore (approssimativamente dalle 8.00 fino a mezzanotte) e dopo 24 ore.
    E.5.2Secondary end point(s)
    Variability in plasma levodopa concentration as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR- CD/LD); AEs and SAEs ; Tolerability ; IR-CD/LD and AP-CD/LD Cmax, Tmax, Cmin, AUC, and elimination half life
    Variabilit¿ della concentrazione plasmatica di levodopa in base alla valutazione del coefficiente di variazione (Coefficient of Variation, CV) (confronto tra AP-CD/LD e IR-CD/LD); Eventi avversi ed eventi avversi gravi; Tollerabilit¿; Cmax, Tmax, Cmin, AUC ed emivita di eliminazione di IR-CD/LD e AP-CD/LD
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK blood sampling will be performed at time 0 and every 30 minutes for 16 hours (from approximately 8:00 AM until midnight) and again at 24 hours on Days 1 and 8; During the trial; During the trial; PK blood sampling will be performed at time 0 and every 30 minutes for 16 hours (from approximately 8:00 AM until midnight) and again at 24 hours on Days 1 and 8.
    Prelievi per le analisi di farmacocinetica saranno effettuati nel Giorno 1 e 8 al tempo 0 e ogni 30 minuti per 16 ore (approssimativamente dalle 8.00 fino a mezzanotte) e di nuovo dopo 24 ore ; Durante tutta la sperimentazione; Durante tutta la sperimentazione; Prelievi per le analisi di farmacocinetica saranno effettuati nel Giorno 1 e 8 al tempo 0 e ogni 30 minuti per 16 ore (approssimativamente dalle 8.00 fino a mezzanotte) e di nuovo dopo 24 ore.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Normal Clinical Practice
    Normale Pratica Clinica
    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 Decision2018-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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