Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Disorder of Consciousness; Hemorrhagic Stroke
• Intervention / Treatment: Drug: Cerebrolysin; Drug: Control

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center Research Coordinating Center
    • Contact: Mi Soo Jang, Ph.D.; Phone Number: +822 20305474; Email: rcc@kuh.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 62 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebrolysin; 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously	Drug: 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	Drug: Control; 100 ml normal saline, days 4-17, once/day, IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positron Emitting Tomography	Assessing the degree of brain neural network activity	2 days after randomization
Coma Recovery Scale - revised	Assessing the degree of disorders of consciousness	2 days after randomization
Coma Recovery Scale - revised	Assessing the degree of disorders of consciousness	17 days after randomization
Positron Emitting Tomography	Assessing the degree of brain neural network activity	17 days after randomization

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Collaborators: Ever Neuro Pharma GmbH

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Stroke; Consciousness Disorders; Hemorrhagic Stroke; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: kuhrm2020no1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No