Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04427241
• Other study ID #: kuhrm2020no1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Hemorrhagic Stroke

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center Research Coordinating Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Konkuk University Medical Center	Ever Neuro Pharma GmbH

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coma Recovery Scale - revised	Assessing the degree of disorders of consciousness	2 days after randomization
Primary	Coma Recovery Scale - revised	Assessing the degree of disorders of consciousness	17 days after randomization
Primary	Positron Emitting Tomography	Assessing the degree of brain neural network activity	2 days after randomization
Primary	Positron Emitting Tomography	Assessing the degree of brain neural network activity	17 days after randomization