NCT04873583 High Dose Steroids in Children With Stroke
| NCT ID | NCT04873583 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Paediatric Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-11-16 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2021-11-16 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Maja Steinlin, Prof. em. Dr. med.
STUDY DIRECTOR
Bern university hospital, Inselspital Bern, Kinderklinik
Frequently Asked Questions
Who can join the NCT04873583 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 17 Years, studying Paediatric Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04873583 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT04873583 currently recruiting?
Yes, NCT04873583 is actively recruiting participants. Contact the research team at maja.steinlin@insel.ch for enrollment information.
Where is the NCT04873583 trial being conducted?
This trial is being conducted at Randwick, Australia, Westmead, Australia, Melbourne, Australia, Innsbruck, Austria and 11 additional locations.
Who is sponsoring the NCT04873583 clinical trial?
NCT04873583 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Maja Steinlin, Prof. em. Dr. med. at Bern university hospital, Inselspital Bern, Kinderklinik. The trial plans to enroll 70 participants.
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