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NCT Number: NCT04427241

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

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

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Key information

Age range

19 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center Research Coordinating Center

Seoul, South Korea

Location status: Recruiting

Location contact

Mi Soo Jang, Ph.D.

CONTACT

[email protected]

20305474 ext. +822

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cerebrolysin

Drug

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

Control

Drug

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

Primary outcomes

  1. Coma Recovery Scale - revised

    Time frame: 2 days after randomization

    Assessing the degree of disorders of consciousness

  2. Coma Recovery Scale - revised

    Time frame: 17 days after randomization

    Assessing the degree of disorders of consciousness

  3. Positron Emitting Tomography

    Time frame: 2 days after randomization

    Assessing the degree of brain neural network activity

  4. Positron Emitting Tomography

    Time frame: 17 days after randomization

    Assessing the degree of brain neural network activity

Study contacts

Contact information is provided by the study sponsor or research team.

Jongmin Lee, M.D., Ph.D.

CONTACT

[email protected]

+821063558073

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Collaborators

  • Ever Neuro Pharma GmbH

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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