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Stroke in childhood due to inflammatory narrowing of blood vessels: Treatment with steroids
EU CTIS ID: 2022-500631-36-00
What this study is testing
The purpose of this study is to evaluate if additional early anti-inflammatory treatment may influence the course of arteriopathy and improve clinical outcome and may prevent stroke recurrence in children with stroke and unilateral focal arteriopathy. The primary objective of this study is to determine if a high dose course of methylprednisolone/prednisolone in addition to standard of care including antithrombotic treatment results in better improvement of focal arteriopathy in children with acute ischemic stroke and focal arteriopathy compared to standard of care alone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.