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

Phase 1

• Conditions: Focal cerebral arteriopathy and childhood stroke Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall diseaseprovoked by infection.; MedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10003209Term: ArteriopathySystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005571-39-AT
• Lead Sponsor: Inselspital, Bern University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-26
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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 CNS
5.5. Unless otherwise defined in the national addendum: Female participants age = 13: Negative pregnancy test (blood and urine)
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous stroke
2.Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
3.Known genetic vasculopathies as e.g. PHACES syndrome, ACTA II
4.Moyamoya or sickle cell disease
5.Small vessel cerebral vasculitis (primary CNS vascularitis)
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:
a.pre-existing progressive neurocognitive dysfunction
b.bilateral MRI lesions/vessel involvement
c.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

Study & Design

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