Focal Cerebral Arteriopathy Steroid Trial

Conditions

• Arterial Ischemic Stroke
• Arteriopathy
• Pediatric Stroke

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Not accepted

Interventions

• methylprednisolone, prednisolone, prednisone — DRUG
  Any generic or brand-name methylprednisolone at the appropriate dose may be used. Likewise, any generic or brand-name prednisolone, or prednisone, at the appropriate dose may be used.

Study Details

This comparative effectiveness trial (CET) in children with suspected focal cerebral arteriopathy (FCA) presenting with arterial ischemic stroke (AIS) or transient ischemic attack (TIA) will compare the use of early corticosteroid treatment (Arm A) versus delayed/no corticosteroid treatment (Arm B). Delayed corticosteroid treatment is given only for those demonstrating disease progression and is initiated as soon as the progression is detected (at any time after randomization). All participants will also receive standard of care therapy (aspirin and supportive care). Sites will randomize participants 1:1 to Arm A or B. Participants will be enrolled and randomized as soon as possible after their stroke/TIA up until 96 hours following the initial stroke/TIA event.

Key Dates

Start date

Oct 1, 2023

Status verified

Jan 2026

Primary completion

Jul 31, 2029

Completion

Jan 31, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A
  Treat all children with suspected FCA with corticosteroids as soon as the diagnosis is made.
• Active Comparator: Arm B
  Treat only the subset of children that develop evidence of FCA disease progression.

Primary Outcome Measure

Change in Focal Cerebral Arteriopathy Severity Score (FCASS) [ Time Frame: Baseline to one month ]

Locations (1)

Find similar trials in San Francisco, CA

Related Studies

• The FBRI VTC Neuromotor Research Clinic
  Recruiting · Virginia Polytechnic Institute and State University · Roanoke, Virginia