Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Overview

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

Full Title of Study: “Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2025

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

Arms, Groups and Cohorts

  • Experimental: Cerebrolysin
    • 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
  • Placebo Comparator: Control
    • 100 ml normal saline, days 4-17, once/day, IV

Clinical Trial Outcome Measures

Primary Measures

  • Coma Recovery Scale – revised
    • Time Frame: 2 days after randomization
    • Assessing the degree of disorders of consciousness
  • Coma Recovery Scale – revised
    • Time Frame: 17 days after randomization
    • Assessing the degree of disorders of consciousness
  • Positron Emitting Tomography
    • Time Frame: 2 days after randomization
    • Assessing the degree of brain neural network activity
  • Positron Emitting Tomography
    • Time Frame: 17 days after randomization
    • Assessing the degree of brain neural network activity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Konkuk University Medical Center
  • Collaborator
    • Ever Neuro Pharma GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jongmin Lee, MD, PhD, Professor – Konkuk University Medical Center

References

Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654.

Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.

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