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Corticosteroid

Corticosteroids for Pediatric Stroke (FOCAS Trial)

Phase 4
Waitlist Available
Led By Heather J Fullerton, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AIS definition: neurological deficit with acute onset (including seizures) and acute infarct(s) corresponding to arterial territory(ies) on brain imaging
Age 1 year through 18 years at stroke/TIA ictus (ineligible as of 19th birthday)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

FOCAS Trial Summary

This trial compares early vs delayed/no corticosteroid treatment for children with suspected stroke or TIA. All participants get aspirin + supportive care. Those in Arm A get early treatment, in B delayed if disease progresses.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares early versus delayed/no steroid treatment in kids after a stroke/TIA due to suspected focal cerebral arteriopathy. Participants will either receive immediate corticosteroids (methylprednisolone/prednisolone/prednisone) or delayed treatment if their condition worsens.See study design
What are the potential side effects?
Corticosteroid side effects can include increased infection risk, changes in mood or behavior, high blood sugar levels, stomach ulcers, bone weakening over time and may affect growth in children.

FOCAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a stroke with sudden symptoms and brain scans showing areas of damage.
Select...
I had a stroke or TIA before turning 19.
Select...
I had a stroke-like episode without lasting brain damage.

FOCAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Focal Cerebral Arteriopathy Severity Score (FCASS)
Secondary outcome measures
Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month (required)
Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month at 12 months (when imaging is available)
Pediatric Stroke Outcome Measure (PSOM) at 12 months (when feasible)
+3 more

FOCAS Trial Design

2Treatment groups
Active Control
Group I: Arm AActive Control1 Intervention
Treat all children with suspected FCA with corticosteroids as soon as the diagnosis is made.
Group II: Arm BActive Control1 Intervention
Treat only the subset of children that develop evidence of FCA disease progression.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,495 Total Patients Enrolled
Medical University of South CarolinaOTHER
933 Previous Clinical Trials
7,394,556 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,546 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Arm A been granted clearance by the FDA?

"There is ample evidence demonstrating the safety of Arm A, thus it has been assigned a 3 on our internal rating scale. This efficacy was determined through Phase 4 trials; indicating that this treatment had already received approval."

Answered by AI

Are there still available vacancies for participation in this clinical trial?

"The records hosted on clinicaltrials.gov demonstrate that this particular trial is no longer accepting applications, as it was initially posted in October 1st 2023 and last edited September 8th of the same year. However, there are 1190 other studies actively recruiting patients at present time."

Answered by AI

Can I join this medical research project?

"In order to be eligible for this research, the participant must have had a pediatric stroke and fall within 1 year old - 18 years old. A total of 80 individuals are required for proper data collection."

Answered by AI

Does the current trial extend to individuals aged twenty and above?

"According to the stipulations of this clinical trial, eligible participants must be at least 1 year old and no more than 18 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Focal Cerebral Arteriopathy Steroid Trial
2023. "Focal Cerebral Arteriopathy Steroid Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040255.
~53 spots leftby Jul 2029
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