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CERebrolysin In CADASIL

NCT05755997 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

  • Cadasil

Interventions

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

Sponsors & Collaborators

  • idv Datenanalyse & Versuchsplanung

    collaborator UNKNOWN

  • XClinical GmbH

    collaborator INDUSTRY

  • Ever Neuro Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Aleš Tomek, MUDr., Ph.D. · Motol University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755997 on ClinicalTrials.gov