CERICA - CERebrolysin In CADASIL - A randomized, double-blind, single-centre, two-period cross-over, placebo-controlled trial on safety and efficacy in patients with genetically proven CADASIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513828-42-00

Enrollment

Registered

2024-09-19

Start date

2023-11-29

Completion date

Unknown

Last updated

2024-09-19

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

Conditions

Cerebral Autosomal Dominant Arteriopathy with subcortical Infarcts and Leukoencephalopathy (CADASIL)

Brief summary

The primary multidimensional outcome ensemble comprises 10 single analysis variables of three dimensions (cognition, mood, imaging characteristics) assessed during and at the end of treatment phases I and II (at months 6, 12, 21, and 27). Month 12 (end of phase I) and Month 27 (end of phase II) are the primary endpoints of the formal cross-over analysis.

Interventions

DRUGSodium chloride Fresenius Kabi 0

DRUG9% infuzní roztok

DRUGCerebrolysin 215

DRUG2mg/ml Injekční roztok

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary multidimensional outcome ensemble comprises 10 single analysis variables of three dimensions (cognition, mood, imaging characteristics) assessed during and at the end of treatment phases I and II (at months 6, 12, 21, and 27). Month 12 (end of phase I) and Month 27 (end of phase II) are the primary endpoints of the formal cross-over analysis.	—

Countries

Czechia

Outcome results

None listed

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