Status:
RECRUITING
High Dose Steroids in Children With Stroke
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
LUMIS International GmbH
Conditions:
Paediatric Stroke
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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...
Detailed Description
Background: Arterial ischemic stroke (AIS) is a rare but devastating condition affecting 2-5/100,000 children/year. Children do not recover better than adults with 2/3 suffering long term neurological...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Previous stroke
- Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
- Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)
- Moyamoya or sickle cell disease
- Small vessel cerebral vasculitis (primary CNS vasculitis)
- Bilateral arteriopathy
- Arterial dissection(s)
- Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
- Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
- Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:
- pre-existing progressive neurocognitive dysfunction
- bilateral MRI lesions/vessel involvement
- small vessel arterial stenosis
- On steroid treatment at disease onset
- Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
- Inability to follow the procedures of the study, e.g. due to language problems
- Participation in another interventional study within the 30 days preceding the indication stroke and during the present study
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04873583
Start Date
November 16 2021
End Date
July 1 2026
Last Update
November 18 2025
Active Locations (35)
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1
Sydney Childrens Hospital Randwick
Randwick, New South Wales, Australia, 2031
2
Sydney Childrens Hospital Network
Westmead, New South Wales, Australia, 2145
3
Melbourne Childrens Hospital
Melbourne, Victoria, Australia, 3052
4
Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck
Innsbruck, Tyrol, Austria, 6020