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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04913831
Other study ID # 4-2021-0085
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 2021
Est. completion date March 2024

Study information

Verified date May 2021
Source Yonsei University
Contact Deog Young Kim
Phone 82-2-2228-3714
Email KIMDY@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration. Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria: - Ischemic or hemorrhagic stroke patients - Stroke with CT or MRI diagnosis - Chronic patients with more than 3 months of stroke onset - Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R) - Age: 19 to 90 years old - A person who voluntarily consents to the clinical trial in writing by the principal or legal representative Exclusion Criteria: - In case of contraindications, including allergies to cerebrolysin - Patients with contraindications to PET - Progressive or unstable stroke - In case of accompanying serious neurogenic disease - Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases. - History of alcohol or other drug addiction within 3 years of onset - In case of accompanying serious liver, kidney, heart, or respiratory disease - If you have the following medical abnormalities (Total serum bilirubin> 4 mg/dL, alkaline phosphatase> 250 U/L, SGOT/AST> 150 U/L, SGPT/ALT> 150 U/L, or creatinine) > 3.5 mg/dL) - In case of having a medical disease that is less than 1 year old - During pregnancy or lactation - Participating in other therapeutic research

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cerebrolysin
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Placebo
physiological saline 100ml, 8-35 days, once/day, intravenous administration

Locations

Country Name City State
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary CRS-R (JFK Coma recovery scale-revised) It is a test that analyzes a total of six functions of hearing, vision, movement, speech, communication, and arousal by item to determine the improvement in the level of consciousness of patients with decreased consciousness. These items are scored to determine whether they are in a minimally conscious state (MCS). up to 11 weeks
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