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Recruiting Phase 4

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

NCT04427241 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2023-06-01
Last updated
2026-05-11

Condition(s) studied

Disorder of ConsciousnessHemorrhagic Stroke

Investigational drug(s) / intervention(s)

Cerebrolysin →Control

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

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

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
120 Years
Healthy volunteers
No
Inclusion Criteria 1. Patients with hemorrhagic stroke confirmed by CT or MRI 2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke 3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment) 4. Age: 19 to 80 years of age 5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative. Exclusion Criteria 1. Patients with confirmed epileptiform discharges on EEG 2. Patients with brain parenchymal defects 3. Patients with advanced liver, kidney, cardiac, or pulmonary disease. 4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators. 5. 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. 6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria). 7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol. 8. Administration of a contraindicated drug is essential for medical purposes. 9. Contraindications to the study drug (cerebrolysin). 10. Participation in another therapeutic study

Primary outcome measure(s)

  • Coma Recovery Scale - revised — 2 days after randomization
    Assessing the degree of disorders of consciousness
  • Coma Recovery Scale - revised — 17 days after randomization
    Assessing the degree of disorders of consciousness
  • Positron Emitting Tomography — 2 days after randomization
    Assessing the degree of brain neural network activity
  • Positron Emitting Tomography — 17 days after randomization
    Assessing the degree of brain neural network activity

Trial sites (1)

FacilityCityRegionStatus
Konkuk University Medical Center Research Coordinating Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04427241 on ClinicalTrials.gov ↗ ← All trials in South Korea