Stroke in childhood due to inflammatory narrowing of blood vessels: Treatment with steroids

Phase 1

• Conditions: Focal cerebral arteriopathy and childhood strokeFocal cerebral arteriopathy (FCA) is an inflammatory vessel wall diseaseprovoked by infection.; MedDRA version: 20.0Level: LLTClassification code: 10003209Term: Arteriopathy Class: 10047065; MedDRA version: 22.1Level: LLTClassification code: 10055221Term: Ischemic stroke Class: 10029205; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-500631-36-00
• Lead Sponsor: Insel Gruppe AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

Previous stroke, Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria: a.pre-existing progressive neurocognitive dysfunction b.bilateral MRI lesions/vessel involvement c.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, Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1, Known genetic vasculopathies as e.g. PHACES syndrome, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified