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Study on High-Dose Methylprednisolone and Prednisolone for Children with Stroke Due to Focal Cerebral Arteriopathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of high-dose steroids in children who have experienced a stroke due to an inflammatory condition called focal cerebral arteriopathy. This condition involves the narrowing of blood vessels in the brain, often triggered by an infection. The study aims to determine if early anti-inflammatory treatment with steroids can improve the condition of the blood vessels and prevent further strokes in affected children.

The medications being tested in this study are methylprednisolone and prednisolone. Methylprednisolone is administered intravenously, meaning it is given directly into a vein, while prednisolone is taken orally, in the form of tablets. These medications are being used in addition to the standard care, which includes treatments to prevent blood clots.

Participants in the study will receive either the steroid treatment or a placebo, alongside their usual care. The study will monitor changes in the severity of the arteriopathy over time, as well as any improvements in neurological function and the recurrence of strokes. The study will last for several months, with follow-up assessments to track the progress and outcomes of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, informed consent from the legal representative is required. This consent is documented by signature.

    Eligibility criteria include age between 6 months and 18 years at the time of stroke, and the ability to be randomized within 48 hours of diagnosis and a maximum of 96 hours after stroke onset.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the presence of unilateral arteriopathy. This includes newly acquired neurological deficits and specific neuroimaging features such as unilateral stenosis or vessel irregularities within the central nervous system.

  3. Step 3

    Treatment phase

    The treatment involves the administration of high-dose methylprednisolone or prednisolone in addition to standard care, which includes antithrombotic treatment.

    The medications are administered either orally or intravenously, depending on the specific product and dosage form. For example, methylprednisolone is available as a solution for injection or infusion, while prednisolone is available in tablet form.

  4. Step 4

    Monitoring and follow-up

    The primary outcome is measured by the change in the FCA Severity Score from baseline to 1 month.

    Secondary outcomes include the assessment of neurological deficits over time, neurocognitive outcomes at 12 months, recurrence-free survival, and changes in the FCA Severity Score at 3 and 6 months.

    Residual vasculopathy is also evaluated at 6 months.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by July 2026. Participants will be monitored throughout the study duration to assess the effectiveness of the treatment and any potential side effects.

Who can join the trial?

7 criteria

  • The legal representative of the child must give their permission for the child to participate, and this must be documented with a signature.
  • The child must be older than 6 months and younger than 18 years at the time of the stroke.
  • The child must be able to be randomly assigned to a treatment group within 48 hours of diagnosis and no later than 96 hours after the stroke started.
  • The child must have a condition called unilateral arteriopathy, which means there is a problem with blood vessels on one side of the brain. This is shown by:
    • Newly appearing problems with movement or sensation, known as neurologic deficits.
    • Specific findings on a type of brain scan called MRA (Magnetic Resonance Angiography), which may show either:
      • Narrowing of a blood vessel on one side, known as unilateral stenosis.
      • Irregularities in the blood vessels on one side within the central nervous system (CNS).
      • For female participants aged 13 and older, a pregnancy test must be negative. This test can be done using blood or urine.

Who cannot join the trial?

7 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently taking medications that might affect the study results.
  • Patients who have had a recent infection that could impact the study.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Methylprednisolone

    This medication is a type of steroid used to reduce inflammation. In this trial, it is given in high doses to children who have had a stroke and have a condition called unilateral focal arteriopathy. The goal is to see if it can help improve the condition of the blood vessels and prevent another stroke.

  • Prednisolone

    Similar to methylprednisolone, this is another steroid used to decrease inflammation. It is also given in high doses as part of the trial to see if it can help improve the health of blood vessels in children who have experienced a stroke, potentially preventing future strokes.

What is already known about the treatment

  • Methylprednisolone

    This medication is administered orally or intravenously and is currently being studied for its potential benefits in treating children with stroke and unilateral focal arteriopathy. It is primarily used as an anti-inflammatory agent to reduce inflammation in the blood vessels, which may help improve outcomes and prevent stroke recurrence. Methylprednisolone works by suppressing the immune system's response, thereby decreasing inflammation at the molecular level. It is classified as a corticosteroid, a type of medication that mimics the effects of hormones produced by the adrenal glands.

  • Prednisolone

    Administered orally, this medication is under investigation for its role in managing childhood stroke and focal cerebral arteriopathy. It is used to reduce inflammation in the blood vessels, potentially improving clinical outcomes and preventing further strokes. Prednisolone acts by inhibiting the immune system's inflammatory response, thus reducing inflammation at the molecular level. It belongs to the pharmacological class of corticosteroids, which are synthetic versions of naturally occurring hormones in the body.

Investigated diseases

Focal Cerebral Arteriopathy – Focal cerebral arteriopathy is an inflammatory condition affecting the walls of blood vessels in the brain. It is often triggered by an infection and can lead to a narrowing of the arteries. This narrowing can disrupt normal blood flow, potentially resulting in a stroke. The disease primarily affects children and can cause neurological symptoms depending on the area of the brain impacted. Over time, the inflammation may either resolve or lead to further complications if not managed.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-500631-36-00Protocol codePASTA-1473Estimated enrolment75 patientsSponsorInsel Gruppe AG

sourced from the EU Clinical Trials Register and site verification

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