NCT05755997

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ever Neuro Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to Placebo in patients with genetically proven CADASIL. In addition, a traditional approach will be taken based on an evaluation of the separate risk and benefit domains in comparison with placebo.

Detailed description

Safety data area collected throughout the study (adverse events, vital signs and laboratory tests) and thereafter in case of ongoing serious adverse events (SAEs) at study endpoint. Optional secondary parameters include analyses of biomarkers (samples of blood, hair, urine, and saliva).

Conditions

• Cadasil

Interventions

Type	Name	Description
DRUG	Cerebrolysin	40 ml Cerebrolysin and 60 ml 0.9% NaCl per day for 4 days every month for 1 year
DRUG	0.9 % NaCl	100 ml 0.9% NaCl per day for 4 days every month for 1 year

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2023-03-06
• Last updated: 2025-02-25

Locations

1 site across 1 country: Czechia