Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Primary Purpose
Disorder of Consciousness, Hemorrhagic Stroke
Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cerebrolysin
Control
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Consciousness
Eligibility Criteria
Inclusion Criteria:
- Patient with Severe traumatic brain injury (GCS ≤8, best available score within 24hrs)
- TBI Confirmed with CT or MRI
- at least 4 weeks after traumatic event
- vegetative state or minimally conscious state secondary to TBI (assessed by CRS-R)
- Patient between 19 and 64 years of age
- Written informed consent obtained from the patient or legally authorized representative
Exclusion Criteria:
- with epileptiform discharge confirmed by EEG
- with parenchymal defect
- with advanced liver, kidney, cardiac or pulmonary disease
- with history of advanced cancer within 2 years
- history of alcohol or substance abuse or dependence within the past two years (DSM-V criteria)
- any significant systemic illness (or unstable medical condition that could lead to difficulties complying with the protocol
- history of treatment with antidepressants, antipsychotic drugs, nootropic drugs, vasodilators
- contraindication from amantadine or cerebrolysin
- current enrolment in another therapeutic study
Sites / Locations
- Konkuk University Medical Center Research Coordinating Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cerebrolysin
Control
Arm Description
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
100 ml normal saline, days 4-17, once/day, IV
Outcomes
Primary Outcome Measures
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Secondary Outcome Measures
Full Information
NCT ID
NCT04427241
First Posted
June 3, 2020
Last Updated
May 25, 2023
Sponsor
Konkuk University Medical Center
Collaborators
Ever Neuro Pharma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04427241
Brief Title
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Official Title
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
Collaborators
Ever Neuro Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness, Hemorrhagic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Description
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline, days 4-17, once/day, IV
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Intervention Description
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
100 ml normal saline, days 4-17, once/day, IV
Primary Outcome Measure Information:
Title
Coma Recovery Scale - revised
Description
Assessing the degree of disorders of consciousness
Time Frame
2 days after randomization
Title
Coma Recovery Scale - revised
Description
Assessing the degree of disorders of consciousness
Time Frame
17 days after randomization
Title
Positron Emitting Tomography
Description
Assessing the degree of brain neural network activity
Time Frame
2 days after randomization
Title
Positron Emitting Tomography
Description
Assessing the degree of brain neural network activity
Time Frame
17 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Konkuk University Medical Center Research Coordinating Center
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Soo Jang, Ph.D.
Phone
20305474
Ext
+822
Email
rcc@kuh.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32057086
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.
Results Reference
background
PubMed Identifier
22375973
Citation
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.
Results Reference
background
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Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
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