Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 120 years old?
Source: NCT04427241, who can take part
Where in South Korea
- Konkuk University Medical Center Research Coordinating CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Konkuk University Medical Center
- Trial code
- NCT04427241
- Record updated
- 11 May 2026
- Original description
Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.Read full original descriptionShow less
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
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
Inclusion: 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: CRS-R assessment); Age: 19 to 80 years of age; Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.
Exclusion: Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators; Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria); Administration of a contraindicated drug is essential for medical purposes; Contraindications to the study drug (cerebrolysin); Patients with advanced liver, kidney, cardiac, or pulmonary disease; History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension; Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol; Patients with confirmed epileptiform discharges on EEG; Patients with brain parenchymal defects; Participation in another therapeutic study.