Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could steroids help kids recover from stroke?

NCT ID NCT04873583

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding high-dose steroids to standard aspirin treatment helps children recover better from a stroke caused by inflamed brain arteries. About 70 children aged 6 months to 18 years will be randomly assigned to receive either steroids plus aspirin or aspirin alone. The goal is to see if steroids reduce artery damage and improve long-term function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone and Prednisolone (steroids)
What this could lead to
If it works, this could point toward a treatment that reduces brain damage and prevents repeat strokes in children with inflammatory arteriopathy.
What could go wrong
This is a relatively small Phase 3 trial (70 children), and steroids have known side effects like immune suppression and mood changes. The benefit over aspirin alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Central Nervous System (CNS) 5. Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine) Exclusion Criteria: 1. Previous stroke 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Arterial ischemic stroke are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ischemic disease ischemic stroke pediatric arterial ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paediatric stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, Cambridgeshire, CB22QQ, United Kingdom

  • Børn og Unge - Aarhus Universitetshospital

    NOT_YET_RECRUITING

    Aarhus, 8200, Denmark

  • Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centrum för Kliniska Barnstudier, Astrid Lindgrens Bansjukhus, Kaolinska Universitetssjukhuset

    NOT_YET_RECRUITING

    Stockholm, 171 76, Sweden

  • Charité-Universitätsmedizin Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Department of Pediatric and Adolescence Medicine Copenhagen University Hospital

    RECRUITING

    Copenhagen, 2100, Denmark

  • Hôpital Femme Mère Enfant Lyon

    RECRUITING

    Bron, Auvergne-Rhône-Alpes, 69677, France

  • Hôpital Necker-Enfants Malades

    RECRUITING

    Paris, Île-de-France Region, 75743, France

  • Hôpital Roger Salengro, CHRU de Lille

    RECRUITING

    Lille, 59037, France

  • Hôpital du Valais

    RECRUITING

    Sion, Valais, 1950, Switzerland

  • Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants

    RECRUITING

    Geneva, 1211, Switzerland

  • Hôpitaux Universitaires Paris Sud

    RECRUITING

    Le Kremlin-Bicêtre, Île-de-France Region, 94275, France

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde

    NOT_YET_RECRUITING

    Linz, Upper Austria, 4020, Austria

  • Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Kidnerspital Zürich

    RECRUITING

    Zurich, 8032, Switzerland

  • L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone

    RECRUITING

    Marseille, Aix-en-Provence, 13005, France

  • LMU Klinikum

    RECRUITING

    München, Bavaria, 80337, Germany

  • Luzerner Kantonsspital, Kinderspital, Neuropädiatrie

    ACTIVE_NOT_RECRUITING

    Lucerne, 6000, Switzerland

  • Medizinische Hochschule Hannover OE 6720

    RECRUITING

    Hanover, 30625, Germany

  • Melbourne Childrens Hospital

    RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Ospedale Regionale di Bellinzona e Valli

    RECRUITING

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Pediatric Neurology Strasbourg - Hautepierre University Hospital

    RECRUITING

    Strasbourg, Alsace, 67098, France

  • Royal Manchester Children's Hospital

    RECRUITING

    Manchester, Lancashire, M139WL, United Kingdom

  • Stiftung ostschweizerisches Kinderspital

    RECRUITING

    Sankt Gallen, 9006, Switzerland

  • Sydney Childrens Hospital Network

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Sydney Childrens Hospital Randwick

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • University Hospital Bristol

    RECRUITING

    Bristol, BS13NU, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, Hampshire, SO166YD, United Kingdom

  • Universitäts Kinderklinik Münster

    RECRUITING

    Münster, Nordrhein-Westfahlen, 48129, Germany

  • Universitätskinderklinik beider Basel

    RECRUITING

    Basel, 4056, Switzerland

  • Universitätsklinik für Kinder und Jugendheilkunde Wien

    RECRUITING

    Vienna, 1090, Austria

  • Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck

    NOT_YET_RECRUITING

    Innsbruck, Tyrol, 6020, Austria

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, Nordrhein-Westfahlen, 40225, Germany

  • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin Klinik für Neuropädiatrie und Muskelerkrankungen

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.