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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500631-36-00
Enrollment
45
Registered
2024-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

The primary outcome is change in FCA Severity Score (FCASS) from baseline to 1 month

Detailed description

Neurological deficits over time as determined by PSOM, RRQ, modified Rankin scale (mRS) and Vineland Adaptive Behaviour Scale (VABS) at 6 and 12 months, Neurocognitive outcome at 12 months, Recurrence-free survival, Change in FCASS at (3) and 6 months, Residual vasculopathy at 6 months

Interventions

DRUGMethylprednisolut 16 mg
DRUGPrednisolon 50 mg JENAPHARM
DRUGpoudre pour solution injectable
DRUGAprednislon 25 mg Tabletten
DRUGSolu-Medrol® 500 mg – Trockenstechampulle mit Lösungsmittel
DRUGcomprimé effervescent
DRUGMETHYLPREDNISOLONE
DRUGAprednislon 5 mg Tabletten
DRUGSolu-Medrol® 1000 mg – Trockenstechampulle mit Lösungsmittel
DRUGPREDNISOLONE
DRUGMethylprednisolut 1000 mg
DRUGMethylprednisolut 32 mg
DRUGMethylprednisolut 250 mg

Sponsors

Insel Gruppe AG
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The primary outcome is change in FCA Severity Score (FCASS) from baseline to 1 month

Secondary

MeasureTime frame
Neurological deficits over time as determined by PSOM, RRQ, modified Rankin scale (mRS) and Vineland Adaptive Behaviour Scale (VABS) at 6 and 12 months, Neurocognitive outcome at 12 months, Recurrence-free survival, Change in FCASS at (3) and 6 months, Residual vasculopathy at 6 months

Countries

Austria, Denmark, France, Germany, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026