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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
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 3, 2020
Last Updated
May 25, 2023
Sponsor
Konkuk University Medical Center
Collaborators
Ever Neuro Pharma GmbH
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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
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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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