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RecruitingNCT04427241Updated May 11, 2026

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

A Phase 4 interventional study of Cerebrolysin and Control in Disorder of Consciousness and Hemorrhagic Stroke, sponsored by Konkuk University Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
19 Years to 120 Years
Sex
All
01

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

02

Conditions studied

  • Disorder of Consciousness
  • Hemorrhagic Stroke
03

Who can participate

Ages eligible
19 Years to 120 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Cerebrolysin

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

    Drug: Cerebrolysin

  • Placebo comparator
    Control

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

    Drug: Control

Interventions

  • DrugCerebrolysin

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

  • DrugControl

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

05

What researchers measure

Primary outcomes

  1. Coma Recovery Scale - revised

    Assessing the degree of disorders of consciousness

    Time frame: 2 days after randomization

  2. Coma Recovery Scale - revised

    Assessing the degree of disorders of consciousness

    Time frame: 17 days after randomization

  3. Positron Emitting Tomography

    Assessing the degree of brain neural network activity

    Time frame: 2 days after randomization

  4. Positron Emitting Tomography

    Assessing the degree of brain neural network activity

    Time frame: 17 days after randomization

06

Study locations

1 of 1 sites recruiting
  • Konkuk University Medical Center Research Coordinating Center
    Seoul, South Korea
    Recruiting
07

References and documents

Publications

  • 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. PubMed 32057086 ↗
  • 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. PubMed 22375973 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04427241
Lead sponsor
Konkuk University Medical Center
Collaborators
Ever Neuro Pharma GmbH
Responsible party
Jongmin Lee, MD, PhD (Professor, Konkuk University Medical Center) — Principal investigator
First posted
Jun 11, 2020
Start date
Jun 1, 2023
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 11, 2026

Study contacts

Jongmin Lee, M.D., Ph.D.
Contact
jongminleemd@gmail.com
+821063558073

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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