High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial

Who is this study for? Patients with Pediatric Stroke
What treatments are being studied? Methylprednisolone+Prednisolone
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:

• Informed consent of the legal representative of the trial participant documented by signature

• Age \> 6 months \& \< 18 years at time of stroke

• Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset

• 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)

• Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)

Locations
Other Locations
Australia
Melbourne Childrens Hospital
RECRUITING
Melbourne
Sydney Childrens Hospital Randwick
RECRUITING
Randwick
Sydney Childrens Hospital Network
RECRUITING
Westmead
Austria
Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck
NOT_YET_RECRUITING
Innsbruck
Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde
NOT_YET_RECRUITING
Linz
Universitätsklinik für Kinder und Jugendheilkunde Wien
RECRUITING
Vienna
Denmark
Department of Pediatric and Adolescence Medicine Copenhagen University Hospital
NOT_YET_RECRUITING
Copenhagen
France
Hôpital Femme Mère Enfant Lyon
RECRUITING
Bron
Hôpitaux Universitaires Paris Sud
RECRUITING
Le Kremlin-bicêtre
Hôpital Roger Salengro, CHRU de Lille
RECRUITING
Lille
L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone
RECRUITING
Marseille
Hôpital Necker-Enfants Malades
RECRUITING
Paris
Pediatric Neurology Strasbourg - Hautepierre University Hospital
RECRUITING
Strasbourg
Germany
Charité-Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin Klinik für Neuropädiatrie und Muskelerkrankungen
NOT_YET_RECRUITING
Freiburg Im Breisgau
Medizinische Hochschule Hannover OE 6720
NOT_YET_RECRUITING
Hanover
LMU Klinikum
RECRUITING
München
Universitäts Kinderklinik Münster
RECRUITING
Münster
Sweden
Centrum för Kliniska Barnstudier, Astrid Lindgrens Bansjukhus, Kaolinska Universitetssjukhuset
NOT_YET_RECRUITING
Stockholm
Switzerland
Universitätskinderklinik beider Basel
RECRUITING
Basel
Ospedale Regionale di Bellinzona e Valli
RECRUITING
Bellinzona
Inselspital Bern
RECRUITING
Bern
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
RECRUITING
Chur
Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants
RECRUITING
Geneva
Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie
RECRUITING
Lausanne
Luzerner Kantonsspital, Kinderspital, Neuropädiatrie
ACTIVE_NOT_RECRUITING
Lucerne
Stiftung ostschweizerisches Kinderspital
RECRUITING
Sankt Gallen
Hôpital du Valais
RECRUITING
Sion
Kidnerspital Zürich
RECRUITING
Zurich
United Kingdom
University Hospital Bristol
RECRUITING
Bristol
Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Royal Manchester Children's Hospital
RECRUITING
Manchester
University Hospital Southampton
RECRUITING
Southampton
Contact Information
Primary
Maja Steinlin, Dr. med.
maja.steinlin@insel.ch
+41 31 6329424
Backup
Kathrin Bochud, PhD
kathrin.zuercher@insel.ch
+41316643472
Time Frame
Start Date: 2021-11-16
Estimated Completion Date: 2026-07
Participants
Target number of participants: 70
Treatments
Experimental: Steroids + Standard of care
Standard of care (including aspirin) and intravenous steroids, followed by oral tapering.
No_intervention: Standard of care
Standard of care (including aspirin)
Related Therapeutic Areas
Sponsors
Collaborators: LUMIS International GmbH, University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov