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

NCT04913831 | Unknown Phase 4 DMC

• 1 other identifier: 4-2021-0085
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

Drug: Cerebrolysin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cerebrolysin DRUG

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

Cerebrolysin

Placebo DRUG

physiological saline 100ml, 8-35 days, once/day, intravenous administration

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Deog Young Kim

  Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

82-2-2228-3714; KIMDY@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)