MedTrace Logo

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

NCT04427241 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-11

No results posted yet for this study

Summary

Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.

Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury

Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV

Comparison: cerebrolysin group versus control group

Outcome: Coma Recovery Scale-revised, FDG-PET signal

Conditions

  • Disorder of Consciousness
  • Hemorrhagic Stroke

Interventions

DRUG

Cerebrolysin

30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously

DRUG

Control

100 ml normal saline, days 4-17, once/day, IV

Sponsors & Collaborators

  • Ever Neuro Pharma GmbH

    collaborator INDUSTRY

  • Konkuk University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT04427241 on ClinicalTrials.gov