AuthorisedTherapeutic confirmatory (Phase III)Interventional

High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial

This research trial is investigating how effective high doses of steroids are in treating a specific type of stroke in children called focal cerebral arteriopathy (FCA). FCA is a condition where blood vessels in the brain become inflamed, often triggered by an infection, which can lead to a stroke. The study aims to find out if steroid medications like methylprednisolone can reduce this inflammation. Researchers will measure changes in the severity of FCA over time, as well as looking at children's movement, thinking, and overall development. This is a large-scale study, comparing different treatments to find the best way to help children recover.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Insel Gruppe AG

Enrolment target

Start

05 Jul 2024

Focal cerebral arteriopathy and childhood stroke Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection.

What is this study about?

This study is about a type of stroke that affects children, called focal cerebral arteriopathy (FCA). When a child has FCA, the blood vessels in their brain become inflamed, which means they swell up and can get damaged. This inflammation is often caused by an infection. This damage can then lead to a stroke. Because the brain is still developing in children, it's really important to find the best ways to treat this condition to help them recover as fully as possible.

Doctors are testing whether strong steroid medicines can help treat this inflammation. Steroids are powerful medicines that can reduce swelling and calm down the immune system. The main goal of this study is to see if these steroid treatments can make the FCA less severe in children after one month. They will also be looking at how children's health, movement, and thinking skills develop over six months and a year.

This is a comparison study, meaning doctors are carefully looking at how different approaches work to find the most effective treatment. The results from this study could help doctors in the future decide on the best way to treat children who have this specific type of stroke.

Key takeaways

This study is for children who have had a stroke caused by focal cerebral arteriopathy (FCA).
It aims to see if high-dose steroid medicines can reduce inflammation in the brain's blood vessels.
Researchers will track how the children's condition and development change over a year.
This is a 'Phase III' study, meaning it's a large-scale trial to confirm treatments.
Participation involves regular check-ups and taking study medication.

Who may be eligible?

This study is looking for children who have had a stroke caused by a condition called focal cerebral arteriopathy (FCA).

Doctors will carefully check each child to make sure they are suitable for the study. This involves making sure they have this particular type of stroke and that they don't have other health conditions that would make taking part unsafe or affect the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Has your child recently had a stroke?
Has a doctor told you your child's stroke was caused by 'focal cerebral arteriopathy' (FCA)?
Is your child under the care of a specialist doctor for their stroke?
Are you able to attend regular hospital appointments for your child?

Answer every question to see your result.

What does participation involve?

If you decide your child takes part, they will receive one of the study medications. These are different forms and doses of steroid medicines, given either as a tablet or an injection. The study will involve regular check-ups with the doctors. These visits will likely include examinations, questions about your child's health, and possibly some scans or other tests to monitor their condition and see how the treatment is working. You will also be asked to answer questions about your child's development and how they are coping. The main parts of the study will involve closely monitoring your child's condition for up to a year, with key assessments at one month, three months, six months, and twelve months after starting the treatment.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving close medical care and potentially a treatment that could help your child's condition. However, it's also important to be aware of potential risks. Steroid medications can have side effects, and the study will monitor for these closely. As with any medical treatment, there's no guarantee the treatment will work for every child, or that your child might not experience side effects. You are free to withdraw your child from the study at any time and for any reason, without it affecting their usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Austria
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Unverified
Germany
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Unverified
Denmark
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Unverified
Sweden

Common questions

What is focal cerebral arteriopathy (FCA)?

FCA is when little blood vessels in a child's brain get swollen and inflamed, often after an infection, which can cause a stroke.

What kind of medicines are being tested?

The study is testing different types and strengths of steroid medicines. Steroids can help reduce swelling and inflammation in the body.

How long will the study last for my child?

Your child's progress will be checked over about a year, with key updates at one, three, six, and twelve months.

Will my child know if they are getting the new treatment?

This is a 'randomised controlled trial,' which means children are put into different groups by chance to compare treatments. You might not know which specific steroid dose or type your child is receiving.

What happens if my child doesn't get better?

Children in the study will receive ongoing medical care, and doctors will adjust treatment if needed, just like they would outside the study.