Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2021-11-16
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.
Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.
Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.
The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.
This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
NCT03781700
Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children
NCT02818738
Glutamine Supplement in MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes) Syndrome
NCT04948138
Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
NCT06838559
A Study to Prevent Infantile Spasms Relapse
NCT06819670
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Rationale: There is increasing evidence that etiologically inflammatory processes play a crucial role in childhood stroke, and influence outcome. Retrospective analyses suggest improved outcome and less recurrence with steroid treatment. With the exception of sickle cell disease, this study will be the first randomized clinical trial in children with arterial ischemic stroke. It will provide high-level evidence for the most appropriate treatment for children with AIS due to FCA. Alignment of interventions and outcome as well as pooled analysis with the planned Focal Cerebral Arteriopathy Steroid (FOCAS) study in North America will allow pooled analysis results.This is very important in view of the marked neurological, social and economic burden of childhood AIS for patients and families. This project has been identified as the most important AIS treatment trial by a Delphi survey of international paediatric stroke experts and is one of the most important research priorities identified by parents. In addition, the study will provide insights into the pathogenesis of inflammatory vasculopathies.The objective of this trial is to show that children with first stroke event due to unilateral FCA treated with a combination of high dose steroid and aspirin will have better and quicker recovery of arteriopathy, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.
The proposed study is a prospective multicentre, parallel group, two-arm, randomized controlled, open-label clinical trial with blinded outcome assessment, comparing a high dose course of methylprednisolone / prednisolone plus standard of care with standard of care alone in children with unilateral arteriopathy and acute ischemic stroke.
Measurements and procedures: Participants will be randomized within 48 hours after diagnosis (maximum 96 hours after stroke onset) to standard of care (SC) alone (control group) or SC plus steroids (experimental group). SC will be harmonized among the study centres to include aspirin treatment. Patients will be assessed at 1, 3, 6 and 12 months. Magnetic imaging and angiography (MRI/MRA) will be done at 1, (3) and 6 months.
Number of Participants: 70 participants in total, 35 per treatment arm
Study duration: 48 months
Study Centre(s): International multi-centre study with approximately 20 to 30 centres
Participating countries:Switzerland, Germany, France, Austria, Great Britain \& Australia
Centres in additional countries might be considered.
Statistical Considerations: The sample size is based on the comparison of the primary outcome - the change in FCASS from baseline to 1 month - between the two treatment groups. The standard deviation from 13 patients of a retrospective study was calculated. The standard deviation of the baseline and follow-up FCASS was 3.0 and 3.3, respectively. The standard deviation of the change in FCASS from baseline was 2.8. Based on the standard deviation of 2.8 and a two-sample means test, 64 patients (32 in each group) are required to detect a difference of 2.0 with a power of 80% at a two-sided alpha-level of 0.05. To account for dropouts (8%), we enlarge the sample size to 70 patients (35 in each group). The primary analysis will follow the intention-to-treat (ITT) principle, i.e. all patients will be analysed in the allocated group regardless of any protocol violations such as cross-overs. The primary outcome (change in FCASS from baseline to 1 month) as well as other secondary continuous score outcomes that are measured multiple times during follow-up (RRQ, mRS, Pediatric Stroke Outcome Measure (PSOM), VABS, modAspect) will be assessed in a repeated-measure, mixed-effects linear model.
Good Clinical Practice (GCP) Statement: This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP) as well as all national legal and regulatory requirements.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Steroids + Standard of care
Standard of care (including aspirin) and intravenous steroids, followed by oral tapering.
Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Prednisolone
Intravenous treatment will be immediately followed by oral tapering with Prednisolone.
Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)
Standard of care
Standard of care (including aspirin)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Prednisolone
Intravenous treatment will be immediately followed by oral tapering with Prednisolone.
Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 Central Nervous System (CNS)
5. Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)
Exclusion Criteria
2. Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
3. Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)
4. Moyamoya or sickle cell disease
5. Small vessel cerebral vasculitis (primary CNS vasculitis)
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:
1. pre-existing progressive neurocognitive dysfunction
2. bilateral MRI lesions/vessel involvement
3. 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
6 Months
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bern
OTHER
LUMIS International GmbH
UNKNOWN
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maja Steinlin, Prof. em. Dr. med.
Role: STUDY_DIRECTOR
Bern university hospital, Inselspital Bern, Kinderklinik
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sydney Childrens Hospital Randwick
Randwick, New South Wales, Australia
Sydney Childrens Hospital Network
Westmead, New South Wales, Australia
Melbourne Childrens Hospital
Melbourne, Victoria, Australia
Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck
Innsbruck, Tyrol, Austria
Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde
Linz, Upper Austria, Austria
Universitätsklinik für Kinder und Jugendheilkunde Wien
Vienna, , Austria
Børn og Unge - Aarhus Universitetshospital
Aarhus, , Denmark
Department of Pediatric and Adolescence Medicine Copenhagen University Hospital
Copenhagen, , Denmark
L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone
Marseille, Aix-en-Provence, France
Pediatric Neurology Strasbourg - Hautepierre University Hospital
Strasbourg, Alsace, France
Hôpital Femme Mère Enfant Lyon
Bron, Auvergne-Rhône-Alpes, France
Hôpital Roger Salengro, CHRU de Lille
Lille, , France
Hôpitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, Île-de-France Region, France
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin Klinik für Neuropädiatrie und Muskelerkrankungen
Freiburg im Breisgau, Baden-Wurttemberg, Germany
LMU Klinikum
München, Bavaria, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Nordrhein-Westfahlen, Germany
Universitäts Kinderklinik Münster
Münster, Nordrhein-Westfahlen, Germany
Charité-Universitätsmedizin Berlin
Berlin, , Germany
Medizinische Hochschule Hannover OE 6720
Hanover, , Germany
Centrum för Kliniska Barnstudier, Astrid Lindgrens Bansjukhus, Kaolinska Universitetssjukhuset
Stockholm, , Sweden
Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie
Lausanne, Canton of Vaud, Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
Chur, Kanton Graubünden, Switzerland
Hôpital du Valais
Sion, Valais, Switzerland
Universitätskinderklinik beider Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants
Geneva, , Switzerland
Luzerner Kantonsspital, Kinderspital, Neuropädiatrie
Lucerne, , Switzerland
Stiftung ostschweizerisches Kinderspital
Sankt Gallen, , Switzerland
Kidnerspital Zürich
Zurich, , Switzerland
Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Royal Manchester Children's Hospital
Manchester, Lancashire, United Kingdom
University Hospital Bristol
Bristol, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Russel Dale, Dr.
Role: primary
Russell Dale, Dr.
Role: primary
Mark MacKay, Prof. Dr.
Role: primary
Christian Lechner, OA Mag. MD
Role: primary
Biebl Ariane, PD MD
Role: primary
Rainer Seidl, Prof. Dr.
Role: primary
Karen Markussen Linnet, PhD
Role: primary
Malene Landbo Børresen, MD PhD
Role: primary
Beatrice Desnous, MD
Role: primary
Vincent Laugel, Pr, MD, PhD
Role: primary
Maryline Carneiro, Dr.
Role: primary
Laure Lacan, MD
Role: primary
Kumaran Deiva, Dr.
Role: primary
Manoëlle Kossorotoff, Dr.
Role: primary
Janbernd Kirschner, Pr., MD
Role: primary
Matthias Eckenweiler, MD
Role: backup
Lucia Gerstl, PD Dr.
Role: primary
Martin Olivieri, MD
Role: backup
Stefani Harmsen, MD
Role: primary
Annette Horn, MD
Role: backup
Timo Deba, MD
Role: primary
Roland Straeter, MD
Role: backup
Marc Nikolaus, MD
Role: primary
Bernhard Weschke, MD
Role: backup
Christian Menke, MD
Role: primary
Helena Marell Hessla, MD
Role: primary
Anna Gunnerbeck, MD
Role: backup
Stéphane Darteyre, MD
Role: primary
Barbara Goeggel Simonetti, PD Dr.
Role: primary
Reta Malär, MD
Role: primary
Susi Strozzi, MD
Role: backup
Nicole Faignart, MD
Role: primary
Claudia Poloni, MD
Role: backup
Alexandre Datta, PD Dr.
Role: primary
Gabriela Oesch Nemeth, MD
Role: primary
Joel Fluss, PD Dr.
Role: primary
Oliver Maier, Dr.
Role: primary
Annette Hackenberg, Dr.
Role: primary
Manali Chitre, MD
Role: primary
Jaspal Singh, Dr.
Role: primary
Dipak Ram, Dr.
Role: primary
Adrew Mallick, Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
Fullerton HJ, Hills NK, Chen H, Dlamini N, Stence NV, Wintermark M; VIPS II Investigators. Changing Management of Focal Cerebral Arteriopathy of Childhood From 2010 to 2022. Stroke. 2025 Jun;56(6):1460-1468. doi: 10.1161/STROKEAHA.124.050550. Epub 2025 May 12.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-500631-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
2021-005571-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2021-00453
Identifier Type: OTHER
Identifier Source: secondary_id
305395
Identifier Type: OTHER
Identifier Source: secondary_id
HREC/78937/RCHM-2022
Identifier Type: OTHER
Identifier Source: secondary_id
1473_PASTA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.