Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
NCT ID: NCT04427241
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
12 participants
INTERVENTIONAL
2023-06-01
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cerebrolysin
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
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
Control
100 ml normal saline, days 4-17, once/day, IV
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
120 Years
ALL
No
Sponsors
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Ever Neuro Pharma GmbH
INDUSTRY
Konkuk University Medical Center
OTHER
Responsible Party
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Jongmin Lee, MD, PhD
Professor
Locations
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Konkuk University Medical Center Research Coordinating Center
Seoul, , South Korea
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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kuhrm2020no1
Identifier Type: -
Identifier Source: org_study_id
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