Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Recruiting now · Phase 4

Conditions studied: Disorder of Consciousness, Hemorrhagic Stroke

In brief

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

Key facts

Study ID

NCT04427241

Run by

Konkuk University Medical Center

People needed

12

Starts

2023-06-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-11

Who can join

Age: 19 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with confirmed epileptiform discharges on EEG
• Patients with brain parenchymal defects
• Patients with advanced liver, kidney, cardiac, or pulmonary disease.
• Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
• 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.
• Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
• Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
• Administration of a contraindicated drug is essential for medical purposes.
• Contraindications to the study drug (cerebrolysin).
• Participation in another therapeutic study

Where it is running

• Konkuk University Medical Center Research Coordinating Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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