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    Summary
    EudraCT Number:2013-000531-27
    Sponsor's Protocol Code Number:NL43510
    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:2018-02-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000531-27
    A.3Full title of the trial
    corticosteroids or clobazam for ESES syndrom: a European, multicenter, randomized, controlled clinical trial
    corticosteroidi o clobazam per la sindorme ESES: studio clinico europeo, multicentrico, randomizzato, controllato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    treatment of ESES syndroom with corticosteroids or clobazam; a European study
    trattamento della sindrome ESES con corticosteroidi o clobazam: uno studio europeo
    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: studio europeo randomizzato di steroidi vs clobazam per il trattamento di encefalopatia
    A.4.1Sponsor's protocol code numberNL43510
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN42686094
    A.5.4Other Identifiers
    Name:dutch CCMO ABR numberNumber:43510
    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 Found
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportWilhelmina Kinderziekenhuis onderzoeksfonds
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportEuropean Clinical Reseach Infrastructures Network
    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 organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointservizio informazione sperimentazio
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584EA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 887555555
    B.5.5Fax number+31 887555350
    B.5.6E-mailf.e.jansen@umcutrecht.nl
    D. IMP Identification
    D.IMP: 1
    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 FRISIUM
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI S.p.A.
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOBAZAM
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCLOBAZAM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.2
    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 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 NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 namesolu medrol
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.4EV Substance Codesub08872mig
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 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: 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 Yes
    D.2.1.1.1Trade name NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOBAZAM
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCLOBAZAM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.2
    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: 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 PREDNISOLONE SODIUM PHOSPHATE - 5 MG SOLUZIONE ORALE 10 CONTENITORI IN PE DA 5 ML MONODOSE
    D.2.1.1.2Name of the Marketing Authorisation holderDOMPE' S.P.A.
    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 nameprednisolone
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISOLONE SODIO FOSFATO
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePREDNISOLONE SODIO FOSFATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 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
    Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome
    Encefalopatia con stato epilettico elettrico nel sonno, chiamato anche sindrome ESES
    E.1.1.1Medical condition in easily understood language
    sleep epilepsy
    epilessia nel sonno
    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 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
    confrontare gli effetti sulla cognizione del trattamento con corticosteroidi o clobazam nei bambini con sindrome ESES
    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.
    Per confrontare gli effetti del trattamento con corticosteroidi o clobazam sul sonno indotto index spike-wave nei bambini con sindrome ESES.
    - Per confrontare gli effetti del trattamento con corticosteroidi o clobazam
    sulla frequenza delle crisi epilettiche nei bambini con sindrome ESES.
    - Per confrontare gli effetti collaterali e la tollerabilità del trattamento con corticosteroidi o clobazam nei bambini con sindrome ESES.
    - Per confrontare gli effetti del trattamento con corticosteroidi o clobazam in bambini con sindrome ESES, misurata con un punteggio VAS.
    - Per valutare i fattori predittivi demografici e correlati alla malattia, compresi i fattori immunologici, di successo del trattamento con
    corticosteroidi o clobazam nei bambini con sindrome ESES.
    - Per identificare un biomarker per l'attività della malattia e la risposta al trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 2 to 12 years
    •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
    • età da 2 a 12 anni
    • nei sei mesi precedenti l'inclusione (preferenzialmente come
    presto) diagnosi di una sindrome tipica o atipica ESES (come definito nel protocollo di studio)
    • Nessun precedente trattamento sia con clobazam che con steroidi
    • Nessun trattamento in corso con carbamazepina, oxcarbazepina, vigabatrin,tiagabina, gabapentin e pregabalin e nessun trattamento con uno di questi
    farmaci nei tre mesi precedenti;
    • consenso informato scritto dai genitori / tutori o rappresentanti legali
    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.
    -pazienti con un indice di ondata picco durante la veglia del> 50%
    • Qualsiasi condizione che, a giudizio del ricercatore, controindica l'uso di clobazam o steroidi.
    E.5 End points
    E.5.1Primary end point(s)
    - Quoziente di intelligenza, o quoziente di sviluppo
    - Sumscore Cognitivo
    Il miglioramento è definito significativo quando migliorata di almeno il 75% di la deviazione standard.
    - Intelligence quotient, or developmental quotient
    - Cognitive sumscore
    Improvement is defined as significant when improved by at least 75% of the standard deviation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after six months
    dopo sei mesi
    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.
    - I singoli risultati assoluti e QI;
    - Indice onda Spike durante il sonno non-REM. il Miglioramento è definito come rdecrease a meno
    25%;
    - Frequenza delle crisi. Miglioramento è definita come una riduzione del 50% o più rispetto
    basale;
    - Il miglioramento globale del funzionamento valutato con un punteggio VAS (-5 a 5)
    - Sicurezza e tollerabilità, come valutato dal verificarsi di gravi eventi avversi;
    - Le differenze di livelli di citochine pro infiammatorie in pazienti con ESES che rispondono a una delle strategie di trattamento rispetto a quelli che non rispondono
    E.5.2.1Timepoint(s) of evaluation of this end point
    after six and 18 months
    dopo 6 e 18 mesi
    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
    Valutazione dell'outcome nascosto da parte del neurofisiologo clinico e neuropsicologo
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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
    bambini
    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 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
    Dopo sei mesi di trattamento, la continua attenzione viene data in base al giudizio del medico curante
    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 ECRIN
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-24
    P. End of Trial
    P.End of Trial StatusOngoing
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