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    Summary
    EudraCT Number:2013-000531-27
    Sponsor's Protocol Code Number:NL43510
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-07-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-000531-27
    A.3Full title of the trial
    Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
    Corticosteroiden of clobazam voor ESES syndroom: een Europees, multicentrum, gerandomiseerd, gecontroleerd klinisch onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of ESES syndrome with corticosteroids or clobazam: a European study
    Behandeling van ESES syndroom met corticosteroiden of clobazam: een Europese studie
    A.3.2Name or abbreviated title of the trial where available
    RESCUE ESES: Randomized European trial of Steroids vs Clobazam Usage for Encephalopathy with ESES
    RESCUE ESES: gerandomiseerde Europese studie van steroiden en clobazam voor encefalopathie met ESES
    A.4.1Sponsor's protocol code numberNL43510
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN42686094
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    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 supportDutch national epilepsy fund (NEF)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportWilhelmina Kinderziekenhuis onderzoeksfonds (WKZ-fund)
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportEuropean Clinical Research Infrastructures Network (ECRIN)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMartindale Pharma
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLuxembourg Institute of Health (former CRP-Santé)
    B.5.2Functional name of contact pointNancy DE BREMAEKER
    B.5.3 Address:
    B.5.3.1Street Address1A rue Thomas Edison
    B.5.3.2Town/ cityStrassen
    B.5.3.3Post code1445
    B.5.3.4CountryLuxembourg
    B.5.4Telephone number+35226 970 804
    B.5.5Fax number+35226 970 810
    B.5.6E-mailecrin@lih.lu
    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 TapClob oral suspension
    D.2.1.1.2Name of the Marketing Authorisation holderMartindale Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    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 INNCLOBAZAM
    D.3.9.1CAS number 22316-47-8
    D.3.9.4EV Substance CodeSUB06673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10/5
    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 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 Yes
    D.2.1.1.1Trade name prednisolon
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNprednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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: 3
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNMethylprednisolone
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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 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: 4
    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 Frisium
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNCLOBAZAM
    D.3.9.1CAS number 22316-47-8
    D.3.9.4EV Substance CodeSUB06673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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: 5
    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 Frisium
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNCLOBAZAM
    D.3.9.1CAS number 22316-47-8
    D.3.9.4EV Substance CodeSUB06673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome
    Encefalopathie met elektrische status epilepticus in slaap, ook ESES syndroom genoemd
    E.1.1.1Medical condition in easily understood language
    Sleep epilepsy
    Epilepsie in slaap
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10032061
    E.1.2Term Other forms of epilepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effects on cognition of treatment with either corticosteroids or clobazam in children with ESES syndrome
    Het vergelijken van de effecten op cognitie van behandeling met corticosteroiden of clobazam in kinderen met ESES syndroom.
    E.2.2Secondary objectives of the trial
    - To compare the effects of treatment with corticosteroids or clobazam on sleep induced spike-wave index in children with ESES syndrome.
    - To compare the effects of treatment with corticosteroids or clobazam on the frequency of seizures in children with ESES syndrome.
    - To compare the side-effects and tolerability of treatment with corticosteroids or clobazam in children with ESES syndrome.
    - To compare the effects of treatment with corticosteroids or clobazam in children with ESES syndrome as measured with a VAS score.
    - To assess demographic and disease-related predictive factors, including immunological factors, of succes of treatment with corticosteroids or clobazam in children with ESES syndrome.
    - To identify a biomarker for disease activity and treatment response.
    - Het vergelijken van de effecten van behandeling met corticosteroiden of clobazam op de piekgolf index in slaap bij kinderen met ESES syndroom, beoordeeld met een EEG.
    - Het vergelijken van de effecten van behandeling met corticosteroiden of clobazam op de aanvalsfrequentie bij kinderen met ESES syndroom
    - Het vergelijken van de bijwerkingen van en verdraagzaamheid van behandeling met corticosteroiden of clobazam bij kinderen met ESES syndroom
    - Het vergelijken van de effecten van behandeling met corticosteroiden of clobazam bij kinderen met het ESES syndroom, gemeten met een VAS score.
    - Het bepalen van demografische en ziekte-gerelateerde predictoren, zoals immunologische factoren, voor het succes van behandeling met corticosteroiden of clobazam bij kinderen met ESES syndroom.
    - Het bepalen van een biomarker voor ziekteactiviteit en reactie op therapie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 2 to 12 years (not including children of 12 years old)
    •A diagnosis within six months prior to study inclusion (preferentially as soon as possible) of either typical or atypical ESES syndrome (as defined in study protocol)
    •No previous treatment with either clobazam or steroids
    •No current treatment with carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin and pregabalin and no treatment with any of these drugs in the previous three months;
    •Written informed consent by parents/tutors or legal representatives
    •Leeftijd 2-12 jaar (kinderen van 12 jaar oud niet inbegrepen)
    • Diagnose typisch of atypisch ESES syndroom, zoals beschreven in protocol minder dan 6 maanden voor inclusie (liefst zo recent mogelijk)
    •Geen eerdere behandeling met clobazam of steroiden
    •Geen huidige behandeling met carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin en pregabalin en geen behandeling met deze middelen in de voorgaande 3 maanden.
    •Geschreven toestemmingsverklaring van ouders of voogd
    E.4Principal exclusion criteria
    •Patients with a spike wave index during wakefulness of > 50%
    •Any condition that, in the investigator’s judgement, contraindicates the use of clobazam or steroids.
    •Patienten met een piekgolf index in waak van meer dan 50%
    •Iedere omstandigheid die, naar beoordeling van de onderzoeker, een contra-indicatie vormt voor het gebruik van clobazam of steroiden.
    E.5 End points
    E.5.1Primary end point(s)
    - Intelligence quotient, or developmental quotient
    - Cognitive sumscore

    Improvement is defined as significant when improved by at least 75% of the standard deviation.
    - Intelligentie quotient of ontwikkelingsquotient
    - Cognitieve somscore

    Verbetering is gedefinieerd als significant wanneer toename van tenminste 75% van de standaarddeviatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after six months
    na zes maanden
    E.5.2Secondary end point(s)
    - Individual absolute test results, and IQ scores;
    - Spike wave index during non-REM sleep. Improvement is defined as a rdecrease to less than 25%;
    - Seizure frequency. Improvement is defined as a reduction of 50% or more as compared with baseline;
    - Global improvement of functioning assessed with a VAS score (-5 to 5)
    - Safety and tolerability, as assessed by the occurrence of serious adverse events;
    - Differences in pro-inflammatory cytokine levels in patients with ESES who respond to either treatment strategies compared to nonresponders.
    - Individuele absolute testresultaten en IQ-scores.
    - Piekgolf index tijdens non-REM slaap. Verbetering is gedefinieerd als daling tot minder dan 25%
    - Aanvalsfrequentie. Verbetering is gedefinieerd als vermindering van 50% of meer ten opzichte van de uitgangssituatie
    - Globale verbetering van functioneren beoordeeld met een VAS score (-5 tot 5)
    - Veiligheid en tolerantie, beoordeeld in de vorm van optreden van ernstige complicaties
    - Verschil in pro-inflammatoire cytokine waarden in patienten die wel op behandeling reageren ten opzichte van patienten die niet op behandeling
    reageren.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after six and 18 months
    Na zes en 18 maanden
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Geblindeerde bepaling van uitkomsten door klinisch neurofysioloog en neuropsycholoog
    Blinded outcome assessment by clinical neurophysiologist and neuropsychologist
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 130
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 130
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Kinderen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    After six months of treatment, the continued care is given according to judgement of the treating physician.
    Na 6 maanden wordt de vervolgbehandeling bepaald door de behandelend specialist.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Clinical Research Infrastructures Network (ECRIN)
    G.4.3.4Network Country Luxembourg
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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