Actively Recruiting
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Led by Konkuk University Medical Center · Updated on 2026-05-11
12
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
K
Konkuk University Medical Center
Lead Sponsor
E
Ever Neuro Pharma GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hemorrhagic stroke confirmed by CT or MRI
- Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
- Patients in a vegetative state or minimally conscious state (Coma Recovery Scale - revised assessment)
- Age between 19 and 80 years
- Patients who have given written informed consent themselves or through a legal representative
You will not qualify if you...
- Patients with confirmed epileptiform discharges on EEG
- Patients with brain parenchymal defects
- Patients with advanced liver, kidney, cardiac, or pulmonary disease
- Patients on chronic treatment with medications that affect consciousness, such as antidepressants, antipsychotics, nootropics, or vasodilators
- History of serious illness within the last two years, including cancer, hematologic, renal, hepatic, coronary artery disease, psychiatric illness, diabetes, myocardial infarction, or epilepsy
- Alcohol or drug abuse or dependence within the last 2 years
- Significant systemic disease or unstable medical condition that may affect study compliance
- Need for administration of a contraindicated drug
- Contraindications to cerebrolysin
- Participation in another therapeutic study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center Research Coordinating Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jongmin Lee, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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