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    Summary
    EudraCT Number:2015-003045-26
    Sponsor's Protocol Code Number:Pearl-PD
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-003045-26
    A.3Full title of the trial
    [18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.
    [18F] FE-PE2I PET/CT-Studie av Dopamintransportörer vid tidig idiopatisk Parkinsonistisk sjukdom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.
    Studie av Dopamintransportörer (signalsubstans i centrala nervsystemet) hos patienter med tidiga tecken på Parkinsons sjukdom.
    A.4.1Sponsor's protocol code numberPearl-PD
    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 SponsorUmeå University Hospital
    B.1.3.4CountrySweden
    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 supportVästerbottens county counsil
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå University Hospital
    B.5.2Functional name of contact pointSusanna Jakobson Mo
    B.5.3 Address:
    B.5.3.1Street AddressUmeå University Hospital
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90185
    B.5.3.4CountrySweden
    B.5.4Telephone number4690785 31 79
    B.5.6E-mailsusanna.jakobson.mo@umu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[18F]FE-PE2I
    D.3.4Pharmaceutical form Solution for injection
    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 INN[18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4′-methylphenyl)nortropane
    D.3.9.2Current sponsor code[18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4′-methylphenyl)nortropane
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    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 DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    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 INNIOFLUPANE (123I)
    D.3.9.1CAS number 155798-07-5
    D.3.9.4EV Substance CodeSUB08221MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    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: 3
    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 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 name15O H2O
    D.3.4Pharmaceutical form Solution for injection
    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 INN[15O]H2O
    D.3.9.2Current sponsor code[15O]H2O
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    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
    Patients with newly clinically diagnosed untreated idiopathic parkinsonism
    Patienter med kliniskt nydiagnostiserad obehandlad idiopatisk parkinsonism.
    E.1.1.1Medical condition in easily understood language
    Patients with early signs of Parkinson's disease will participate in the study.
    Patienter som just fått tecken på Parkinsons sjukdom kommer att delta i studien.
    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 HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    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 diagnostic potential of [18F] FE PE2I PET in early untreated parkinsonian disease
    To "head-to-head" compare the diagnostic accuracy of the index test (with [18F] FE PE2I PET / CT) with the reference test (123I-FP-Cit, DaTSCAN ™ SPECT/CT) in newly onset idiopathic parkinsonism
    Att utvärdera den diagnostiska potentialen av 18F FE-PE2I vid tidig parkinsonsitisk sjukdom
    Att ”head-to-head” jämföra indextestet (med 18F FE-PE2I PET/CT) med referenstestet (123I-FP-Cit, DaTSCAN™ SPECT/CT) avseende diagnostisk potential vid nydebuterad parkinsonistisk sjukdom.

    E.2.2Secondary objectives of the trial
    -To assess whether the initial dynamic phase (K1) at [18F] FE PE2I PET / CT can be used to assess rCBF
    -To Investigate whether polymorphisms in the DAT-1 gene affects the BPND (and possibly the relative specific uptake) of 18F FE PE2I
    -To Investigate the relationship between BPND (and possibly the relative specific uptake) of [18F] FE PE2I and clinical parameters, and to assess the relationship between BPND of [18F] FE PE2I and structural and functional MRI in relevant brain areas
    -To evaluate scanning protocols, dosing and image reconstruction methods for [18F] FE PE2I PET / CT
    -To analyze safety parameters at 18F PE2I PET / CT















    -Att pröva om den initiala dynamiska blodflödesfasen (K1) vid 18F FE-PE2I PET/CT kan användas för att värdera rCBF
    -Att undersöka om polymorfism i DAT-1 genen påverkar BPND (ev. relativt specifikt upptag) av 18F FE-PE2I
    -Att undersöka relationen mellan BPND (ev. relativt specifikt upptag) av 18F FE-PE2I och kliniska parametrar att undersöka relationen mellan BPND av 18F FE-PE2I och strukturell och funktionell MRI i relevanta hjärnområden
    -Att evaluera scanningprotokoll, dosering och utvärderingsmetoder för 18F FE-PE2I PET/CT
    -Att analysera säkerhetsparametrar vid 18F-PE2I PET/CT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for patients
    -Woman or man, age 45-80 years who has given written informed consent to participate in the study
    - For a woman in childbearing age: Negative pregnancy test in connection with inclusion and consent to the use of effective contraception (the so-called Pearl index < 1 in accordance with the Medical Products Agency recommendations) , or abstinence until 24 hours after [ 18F ] FE PE2I PET / CT respectively . 72h after DaTSCAN ™ SPECT / CT.
    The following contraceptive methods provide, when used properly , a so-called Pearl index < 1: combined pills or middle-dosed gestagen oral contraceptive pills (not mini-pills ) , intra-uterine device ( IUD or IUS ) , implants , vaginal ring , contraceptive injection or transdermal patch . Female sterilization (bilateral tubarocklusion ) or sterilized male partner ( vasectomy ) is also accepted .
    -Idiopathic Parkinsonism according to UK PDSBB clinical criteria for parkinsonism:
    Bradykinesia + At least two of these:
    • Muscular rigidity
    • 4-6 Hz resting tremor
    -Postural Instability (not primary visual / vestibular / proprioceptive dysfunction)
    -Clinical diagnosis during the period of inclusion = idiopathic parkinsonism (NB not previously known diagnosis)
    -At the time of Inclusion permanent reside in the county of Västerbotten.

    Inclusion criteria for healthy subjects:
    -Woman or man, age ≥60-80 years who has given written informed consent to participate in the study
    -Subjective in generally good health for his/her age
    -Objective generally good health.
    -No known or suspected present disease of the nervous system (neurological or psychiatric)
    -At the time of Inclusion permanent reside in the county of Västerbotten.







    Inklusionskriterier för patienter
    -Kvinna eller man, ålder 45-80 år som har lämna informerat skriftligt samtycke till att delta i studien
    -För kvinna i fertil ålder: Negativt graviditetstest i samband med inklusion samt samtycke till användande av effektiv antikonceptionsmetod (med ett s.k. pearl-index <1 i enlighet med läkemedelsverkets rekommendationer), alternativt avhållsamhet tills 24 h efter [18F]FE-PE2I PET/CT resp. 72h efter DaTSCAN™ SPECT/CT.
    Följande antikonceptiva metoder ger, vid korrekt användning, ett s.k. pearl index på <1: kombinerade p-piller, mellanpiller (dock ej minipiller), intrauterint preventivmedel (kopparspiral eller hormonspiral), p-stav, p-ring, p-spruta eller p-plåster. Kvinnlig sterilisering (bilateral tubarocklusion) eller steriliserad manlig partner (vasektomi) accepteras även.
    -Idiopatisk parkinsonism enligt UK PDSBB:
    Bradykinesi + Minst 2 av dessa:
    • Muskulär rigiditet
    • 4-6 Hz vilotremor
    -Postural instabilitet (ej primär visuell/vestibulär/proprioceptiv dysfunktion)
    -Klinisk diagnos under inklusionsperioden = idiopatisk parkinsonism (OBS! ej tidigare känd diagnos)
    -Vid inklusion permanent boende i Västerbottens län.

    Inklusionskriterier för friska studiedeltagare:
    -Kvinna eller man, ålder ≥60-80 år som har lämna informerat skriftligt samtycke till att delta i studien
    -Subjektivt vid allmänt god hälsa för åldern
    -Objektivt allmänt god hälsa.
    -Ingen känd eller misstänkt nuvarande sjukdom i nervsystemet (neurologisk eller psykiatrisk)
    -Vid inklusion permanent boende i Västerbottens län.
    E.4Principal exclusion criteria
    Principal exclusion criteria (list the most important, max 5000 characters)
    -Severe ongoing medical condition that can be predicted to impair full participation in the study (e.g. treatment of cancer)
    - Disease which prevents imaging (eg PET/CT, SPECT and MR) in prone position (e.g. severe heart failure, severe backache)
    - History of stroke, TIA or known other serious neurological / neurodegenerative disorders (e.g., brain tumor, multiple sclerosis, ALS)
    - Secondary parkinsonism (e.g. drug-induced Parkinsonism or obvious vascular parkinsonism)
    -Known hypersensitivity to iodine
    -Claustrophobia or other contraindication for MRI (e.g pacemaker or magnetic implant etc)
    -Depression or other severe psychiatric condition in need of treatment (psychosis or similar severity)
    -Dementia or MMSE <24
    -Severe hypertension (> 180/110 mmHg)
    -History of drug abuse (e.g. central stimulants or alcohol; nicotine use excepted)
    -Pregnancy or breast-feeding
    -Not willing to participate in the study
    Exklusionskriterier:
    -Svår pågående somatisk sjukdom som kan förutses försvåra deltagandet i hela studien (t.ex. behandlingskrävande cancer)
    -Sjukdom som omöjliggör PET/SPECT eller MR-kameraundersökning i liggande (ex grav hjärtsvikt, svår ryggvärk)
    -Tidigare stroke, TIA eller känd annan allvarlig neurologisk/neurodegenerativ sjukdom (t.ex. hjärntumör, MS, ALS)
    -Sekundär parkinsonism (ex. läkemedelsinducerad parkinsonism eller uppenbar vaskulär parkinsonism)
    -Känd överkänslighet mot jod
    -Klaustrofobi eller annan kontraindikation mot undersökning i MR-kamera (såsom pacemaker, magnetiska implantat etc.)
    -Depression eller annan behandlingskrävande psykiatrisk sjukdom (psykossjukdom eller liknande allvarlighetsgrad)
    -Demens eller MMSE <24
    -Svår hypertoni (>180/110 mmHg)
    -Missbruksanamnes (ex. centralstimulantia eller etyl; nikotinbruk är dock ej exklusionskriterium)
    -Graviditet eller amning
    -Ej villig att medverka i studien
    E.5 End points
    E.5.1Primary end point(s)
    -Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain
    -Statistical difference in the sensitivity and specificity of PET / CT with 18F FE PE2I (Index test) compared to SPECT / CT imaging with 123I-FP-Cit (reference test)
    -Sensitivitet, specificitet och prediktiva värden för PET/CT med 18F FE-PE2I i striatum och extrastriatalt i hjärnan
    -Statistisk skillnad i sensitivitet och specificitet för PET/CT med 18F FE-PE2I (indextest) jämfört med SPECT/CT med 123I-FP-Cit (referenstest)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final calculation of the primary outcome measurements can be made after the clinical follow-up, two years after the imaging, when the clinical diagnosis is reassessed (gold standard in this study). An interim preliminary calculation may be done after the participants have completed [18F] FE PE2I PET/CT (index test) and 123I-FP-Cit SPECT / CT imaging (reference test)
    Den slutliga beräkningen av de primära utfallsmåtten kan göras först efter den kliniska uppföljningen 2 år efter imagingundersökningrana, då den kliniska diagnosen (gold standard i denna studie) har uppdaterats, interimistiska utvärderingar för preliminär beräkning kan dock göras efter att deltagarna har genomfört 18F FE-PE2I PET/CT (indextest) och 123I-FP-Cit SPECT/CT med (referenstest)
    E.5.2Secondary end point(s)
    - Statistical correlation between the initial dynamic phase (K1) of [18F] FE PE2I PET / CT and 15O H2O PET / CT
    - Statistical relationship between BPND (and relative specific uptake) of [18F] FE PE2I in the presence of 9R or 10R-alleles of the DAT1 gene (SLC6A3) respectively
    - Statistical correlation between BPND (and relative specific uptake) of [18F] FE PE2I and UPDRS-III,
    H & Y, age and gender
    - Statistical correlation between [18F] FE PE2I PET / CT and MRI in the relevant brain areas
    - Adequate dosing and scanning procedure
    - Effective radiation dose
    - Adverse events
    -Statistisk korrelation mellan initial dynamisk blodflödesfas (K1) vid [18F]FE-PE2I PET/CT och 15O H2O PET/CT
    -Statistiskt samband mellan BPND (ev. relativt specifikt upptag) [18F]FE-PE2I och förekomst av 9R resp. 10R-allelen av DAT1-genen, (SLC6A3)
    -Statistiskt samband mellan BPND (ev. relativt specifikt upptag) av [18F]FE-PE2I och UPDRS-III, H & Y, ålder och kön
    -Statistiska samband mellan [18F]FE-PE2I PET/CT och MRI i relevanta hjärnområden
    -Adekvat dosering och scanningprocedur
    -Effektiv stråldos
    -Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final calculation of the secondary outcome measurements may be made after the participants have completed [18F] FE PE2I PET/CT
    Den slutliga beräkningen av de sekundära utfallsmåtten kan göras efter att deltagarna har genomfört 18F FE-PE2I PET/CT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    In this project 15O H2O PET / CT will be done to asess regional cerebral perfusion in order to determine if there is a sufficient correlation between 15O H2O PET / CT and the early flow phase (K1) after injection of [18F] FE PE2I If the correlation between the early flow phase after administration of [18F] FE PE2I and 15O H2O is satisfactory, a single dose [18F] FE PE2I PET / CT may be used for both imaging of DAT function and rCBF, an advantage in the diagnosis of early parkinsonian disease.
    I detta projekt vill vi studera rCBF med 15O H2O PET/CT för att utröna om det finns korrelation mellan 15O H2O PET/CT och den tidiga flödesfasen efter injektion av [18F]FE-PE2I och eventuella skillnader mellan friska och patienter med tidig IPS. Om likheterna mellan den tidiga flödesfasen efter tillförsel av [18F]FE-PE2I resp. 15O H2O är tillräckligt stora skulle en dos [18F]FE-PE2I PET/CT kunna användas för att både avbilda DAT-funktion och rCBF, en stor fördel vid utredning av oklar IPS.
    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 No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States No
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-09-15. Yes
    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 state105
    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)
    None
    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 Decision2015-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-11
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