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New treatment option for Paediatric Stroke
Official title High Dose Steroids in Children With Stroke
ClinicalTrials.gov ID: NCT04873583
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for paediatric stroke.
Also referred to as Solu-Medrol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
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
You likely can't join if
- 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...
- Moyamoya or sickle cell disease
- Small vessel cerebral vasculitis (primary CNS vasculitis)
- Bilateral arteriopathy
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 Central Nervous System (CNS)
- Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)
- 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 treatment study within the 30 days preceding the indication stroke and during the present study
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- Melbourne, Victoria, Australia
- Innsbruck, Tyrol, Austria
- Linz, Upper Austria, Austria
- Vienna, Austria
- Aarhus, Denmark
- Copenhagen, Denmark
- Marseille, Aix-en-Provence, France
- Strasbourg, Alsace, France
- Bron, Auvergne-Rhône-Alpes, France
- Lille, France
- Le Kremlin-Bicêtre, Île-de-France Region, France
- Paris, Île-de-France Region, France
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- München, Bavaria, Germany
- Düsseldorf, Nordrhein-Westfahlen, Germany
- Münster, Nordrhein-Westfahlen, Germany
- Berlin, Germany
- Hanover, Germany
+ 15 more site(s).
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, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia; Westmead, New South Wales, Australia; Melbourne, Victoria, Australia; Innsbruck, Tyrol, Austria; Linz, Upper Austria, Austria; Vienna, Austria and 29 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.