Corticosteroids for Pediatric Stroke
(FOCAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how corticosteroids (such as Methylprednisolone, Prednisolone, and Prednisone) might benefit children who have experienced a stroke or mini-stroke (TIA) due to a specific condition affecting brain blood vessels. The study compares two approaches: administering corticosteroids immediately after diagnosis or delaying use until the condition worsens. All participating children will also receive standard treatments like aspirin. Children who have had a stroke or mini-stroke in the past four days and show certain brain imaging results qualify as good candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that all participants will receive standard care, including aspirin. If you are currently on corticosteroids, you may need to stop, as recent corticosteroid treatment is an exclusion criterion.
What is the safety track record for these treatments?
In a previous study, children who had a stroke and received high doses of steroids like methylprednisolone, prednisolone, and prednisone showed better recovery and fewer repeat strokes. This suggests these treatments might be safe and helpful. A European study also found that steroid treatment improved recovery for children with a specific type of brain artery problem called focal cerebral arteriopathy (FCA).
While steroids are usually safe for children, they can have some side effects, such as increased hunger, mood changes, and trouble sleeping. However, these side effects are typically mild and temporary.
In this Phase 4 trial, researchers are closely examining the safety of these treatments. Extensive prior use and study of these treatments help ensure their safety for children who have had a stroke.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using corticosteroids for pediatric stroke because these treatments might offer faster and more direct ways to reduce brain inflammation compared to current options. While most treatments focus on managing symptoms after a stroke, corticosteroids like Methylprednisolone, Prednisolone, and Prednisone work by actively reducing inflammation, potentially preventing further damage. Additionally, the trial explores whether administering these drugs early or selectively can make a significant difference in outcomes, which could lead to more personalized and effective care for young patients.
What evidence suggests that this trial's treatments could be effective for pediatric stroke?
Research has shown that medications called corticosteroids, such as methylprednisolone, prednisolone, and prednisone, can help children recover from a stroke. These treatments lower the risk of another stroke and aid in healing from the first one. In this trial, participants in Arm A will receive corticosteroids as soon as doctors diagnose focal cerebral arteriopathy (FCA), while those in Arm B will receive corticosteroids only if there is evidence of FCA disease progression. A study in Europe found that corticosteroids might be especially useful for children with FCA, a condition where blood vessels in the brain become narrow. Other research found that children who took steroids often recovered better and had fewer long-term problems. This suggests that starting corticosteroid treatment early could be beneficial for children who have had a stroke.12367
Who Is on the Research Team?
Heather J Fullerton, MD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for children aged 1-18 who've had a stroke or TIA within the last 4 days, with imaging showing signs of focal cerebral arteriopathy. They must be able to return for follow-up MRI/MRA scans. Kids on recent steroids, pregnant/post-partum/nursing, with prior strokes or other specific risk factors are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive corticosteroid treatment based on randomization to Arm A or Arm B
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methylprednisolone
- Prednisolone
- Prednisone
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Medical University of South Carolina
Collaborator
American Heart Association
Collaborator
University of Cincinnati
Collaborator
University of Iowa
Collaborator
M.D. Anderson Cancer Center
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
University of Colorado, Denver
Collaborator