Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study

NCTNCT04913831Other id4-2021-0085

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 30 participants (estimated)
Sponsor: Yonsei University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
South Korea
Start: Jun 2021 (estimated)
Primary completion: Mar 2024 (estimated)
Completion: Mar 2024 (estimated)
First posted: 4 Jun 2021
Last update posted: 4 Jun 2021
Conditions: Stroke

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 4
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
NCT04913831
est. Jun 2021 to est. Mar 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CerebrolysinDrug
PlaceboDrug

Arms2

Experimental
Cerebrolysin
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

CRS-R (JFK Coma recovery scale-revised)
Time frame · up to 11 weeks
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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