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    Summary
    EudraCT Number:2021-005571-39
    Sponsor's Protocol Code Number:4859
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-005571-39
    A.3Full title of the trial
    High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy:
    A Multicentre Randomized Controlled Trial
    Hochdosierte Steroide bei Kindern mit Schlaganfall und einseitiger fokaler Arteriopathie:
    Eine multizentrische, randomisierte, kontrollierte Studie
    Accident vasculaire cérébral consécutif à une vasculopathie inflammatoire durant l'enfance, traitment par forte dose de stéroides :
    Une étude multicentrique randomisée, controlee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stroke in childhood due to inflammatory narrowing of blood vessels:
    Treatment with steroids
    Schlaganfall im Kindesalter aufgrund einer entzündlichen Verengung der Blutgefäße:
    Behandlung mit Steroiden
    Traitement par stéroïdes lors de maladie des vaisseaux sanguins après un accident relative aux vaisseaux sanguins cérébraux (AVC) chez l'enfant
    A.3.2Name or abbreviated title of the trial where available
    PASTA (Paediatric Arteriopathy Steroid Aspirin) trial
    PASTA, Hochdosierte Steroide bei Kindern mit Schlaganfall
    PASTA (Pédiatrique Artériopathie Steroïde Aspirine)
    A.4.1Sponsor's protocol code number4859
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04873583
    A.5.4Other Identifiers
    Name:CTU Bern Study-NrNumber:1473_PASTA
    Name:BASEC-NrNumber:2021-00453
    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 SponsorInselspital, Bern University Hospital
    B.1.3.4CountrySwitzerland
    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 supportSwiss National Science Fondation (Schweizerischer Nationalfonds)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInselspital, Bern University Hospital
    B.5.2Functional name of contact pointMaja Steinlin
    B.5.3 Address:
    B.5.3.1Street AddressFreiburgstrasse 15
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3010
    B.5.3.4CountrySwitzerland
    B.5.6E-mailmaja.steinlin@insel.ch
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylprednisolone
    D.3.9.1CAS number 83-43-2
    D.3.9.4EV Substance CodeSUB08872MIG
    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.2.1.1.2Name of the Marketing Authorisation holderPfizer AG and Spirig HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    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
    Focal cerebral arteriopathy and childhood stroke
    Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease
    provoked by infection.
    E.1.1.1Medical condition in easily understood language
    Childhood stroke and inflammatory blood vessel wall disease caused by infection.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003209
    E.1.2Term Arteriopathy
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to evaluate if additional early anti-inflammatory treatment may influence the course of arteriopathy and improve clinical outcome and may prevent stroke recurrence in children with stroke and unilateral focal arteriopathy.
    The primary objective of this study is to determine if a high dose course of methylprednisolone/prednisolone in addition to standard of care including antithrombotic treatment results in better improvement of focal arteriopathy in children with acute ischemic stroke and focal arteriopathy compared to standard of care alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine if a high dose course of methylprednisolone/prednisolone in addition to standard of care including antithrombotic treatment:
    • Improves functional clinical outcomes (measured by Recurrence and Recovery Questionnaire (RRQ), modified Rankin Scale (mRS), Paediatric Stroke Outcome measure (PSOM), and Vineland Adaptive Behaviour Scale (VABS))
    The Recurrence and Recovery Questionnaire (RRQ) and the Paediatric Stroke Outcome measure (PSOM), although not identical, assess closely related aspects of recovery
    • Improves neurocognitive outcome
    • Reduces residual stenotic arteriopathy measured by FCASS (Focal Cerebral Arteriopathy Scaling System)
    • Decreases the final infarct volume measured by the modASPECTS (modified paediatric ASPECTS, Alberta stroke program early CT score)
    • Decreases recurrence risk of stroke
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Informed consent of the legal representative of the trial participant documented by signature
    2. Age > 6 months & < 18 years at time of stroke
    3. Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
    4. Unilateral arteriopathy according to the following criteria:
    • Newly acquired neurologic deficits
    • Specific neuroimaging (MRA) features of either
    - unilateral stenosis, or
    - unilateral vessel irregularities within the CNS
    5. 5. Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood and urine)
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Previous stroke
    2. Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
    3. Known genetic vasculopathies as e.g. PHACES syndrome, ACTA II
    4. Moyamoya or sickle cell disease
    5. Small vessel cerebral vasculitis (primary CNS vascularitis)
    6. Bilateral arteriopathy
    7. Arterial dissection(s)
    8. Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
    9. Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
    10. Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:
    a. pre-existing progressive neurocognitive dysfunction
    b. bilateral MRI lesions/vessel involvement
    c. small vessel arterial stenosis
    11. On steroid treatment at disease onset
    12. Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
    13. Inability to follow the procedures of the study, e.g. due to language problems
    14. Participation in another interventional study within the 30 days preceding the indication stroke and during the present study
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is
    • change in FCA Severity Score (FCASS) from baseline to 1 month
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome is a change (of FCASS) and in hence measured at two timepoints
    * baseline
    * 1 month
    E.5.2Secondary end point(s)
    Secondary outcomes are
    a) Functional impairment outcome measured by PSOM at 1, 3, 6 and 12 months.
    The neurological outcome will be assessed using the PSOM (paediatric stroke outcome measure). The PSOM has been specifically developed and validated for paediatric stroke patients and addresses paediatric specific domains such as development, behaviour and cognition in addition to sensory-motor and language function.
    b) Recovery assessed by RRQ (Recurrence and Recovery Questionnaire)) at 1, 3, 6, and 12 months.
    The Paediatric Recurrence and Recovery Questionnaire (RRQ) was specifically developed and validated for paediatric stroke patients and addresses paediatric- specific problems of manifestation of stroke and also difficulties in reliable clinical examination.
    c) Degree of disability or dependence by mRS (modified Rankin Scale) at 1, 3, 6, and 12 months.
    d) Clinical outcome by Vineland adaptive behaviour scale (VABS) at 6 and 12 months.
    The VABS is a well validated instrument to monitor cognitive and behaviour problems of children by interview. It is used widely in studies with children, as e.g. in a similar steroid treatment trial in infantile spasms.
    e) For Children 2 -18 years, Quality of Life evaluation will be done at 12 month, using the Pediatric Stroke Quality of Life Measure (PSQLM)
    f) Neurocognitive outcome measured at 12 months
    • Intelligence: For Children between 2 -18 years intelligence will be assessed by Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV, as age appropriate) (range=40-160, the higher the score the better the performance)
    • Executive Function: Children > 8 years will undergo specific evaluation of executive function (EF). They will be assessed with the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test, Delis-Kaplan Executive Function System (D-KEFS) Color-Word-Interference Test (range=1-19, the higher the score the better the performance)
    • Attention: Children > 8 years will undergo specific evaluation of attention. They will be assessed with the Continuous performance task (CPT-III). (range=20-80, the higher the score the better the performance)
    g) Change in FCASS from baseline to 6 months.
    Two neuroradiologists will independently score the FCASS; a panel of three neuroradiologists will adjudicate disagreements.
    For participants with available imaging at 3 months, the change in FCASS form baseline to 3 months will additionally be evaluated.
    h) Volume of stroke at baseline, 1, 3 (if imaging is available) and 6 months measured by modASPECTS in diffusion-weighted MRI (DWI) and fluid-attenuated inversion recovery (FLAIR) images.
    ModASPECTS provides a semi quantitative measure of infarct volume in childhood stroke where each abnormal area is assigned one point. Higher scores represent greater volumes, with a maximum possible score of 30 (15 per hemisphere). ModASPECTS is shown to correlate with volume measurements of stroke area.
    i) Residual vasculopathy at 6 months measured by FCASS
    j) Stroke recurrence during the first 12 months after index stroke, assessed at 1, 6 and 12 months.
    Stroke recurrence is defined as
    (i) new focal neurological deficit(s)
    (ii) worsening of the neurological deficits by > 4 pedNIHSS points lasting for more than 24 hours with new or increased diffusion restriction at the time of recurrence (with or without FLAIR/T2 lesions) in the corresponding vascular territory, or
    (iii) new areas of clinically silent infarction, remote from the initial infarct (at 1 and 6 months).
    The neurological deficit has to be verified by a child neurologist. The infarction on MRI will be assessed by two independent paediatric neuroradiologists and ultimately determines presence or absence of stroke. Stroke recurrence will be measured as proportion in each group.
    k) Stroke recurrence at 6 and 12 months after index stroke in relation to the initial degree of vessel stenosis as measured by change in FCASS from baseline to follow-up. Stroke recurrence will be measured as proportion in each category of vessel stenosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes are evluated at 1, 3, 6 and 12 months respectively, see E.5.2.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    None. Investigational arm: Steroids and standard of care; Control arm: Standard of care
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    France
    Switzerland
    Germany
    United Kingdom
    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
    The study end is defined as the moment of database lock, after the last patient had the last visit LVLS.

    During the period of data cleaning and completeness checks performed in the clinical database after LVLS, there is a chance that the site has to contact a participant to clarify an issue or collect missing information.
    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 months0
    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: 70
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    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 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 2022-01-26. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Two groups will not be able to give consent/assent personally
    * Children too young to assent/consent
    * Children with a stroke too severe to allow them to participate in the informed consent procedure
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 70
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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