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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Universitaire De Lille	Lille	France
Hopital Necker Enfants Malades	Paris	France
Universitätsklinikum Freiburg	Freiburg Im Breisgau	Germany

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Karolinska University Hospital	Solna	Sweden
Hospital Femme Mere Enfant	Bron	France
Ludwig Maximilian University Of Munich	Munich	Germany
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Bicetre Hospital	Le Kremlin-Bicetre	France
CHU Brest / Hôpital Morvan	Brest	France
Tjhqz Kgtyzgvg Gvdn	Innsbruck	Austria
Abwysablsj Pmqofeip Hsnczwta Dg Mvjnabbsy	Marseille	France
Ufqmoypsxpiwokclzxpra Dtctmgyckxf Asq	Duesseldorf	Germany
Upgjdcpaaasmmfqnqwolf Mlptkmcg Agd	Munster	Germany
Jsaahwyg Kibyuw Ucowdzvtdm	Linz	Austria
Hkraykas Uzyqwpjhrasehf Svdgpjgiep &lfveay Hylpbgr dm Hndyoalwojt	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	16.05.2022
Denmark	Not yet recruiting	16.05.2022
France	Not yet recruiting	16.05.2022
Germany	Not yet recruiting	16.05.2022
Sweden	Not yet recruiting	16.05.2022

Trial locations

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.

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 ID:

2022-500631-36-00

Protocol code:

PASTA-1473

NCT ID:

NCT04873583

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?