Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

NCT04427241 | Unknown Phase 4 DMC

• 1 other identifier: kuhrm2020no1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Disorder of Consciousness; Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (4)

• Coma Recovery Scale - revised

  Assessing the degree of disorders of consciousness

  2 days after randomization

• Coma Recovery Scale - revised

  Assessing the degree of disorders of consciousness

  17 days after randomization

• Positron Emitting Tomography

  Assessing the degree of brain neural network activity

  2 days after randomization

• Positron Emitting Tomography

  Assessing the degree of brain neural network activity

  17 days after randomization

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously

Drug: Cerebrolysin

Control

PLACEBO COMPARATOR

100 ml normal saline, days 4-17, once/day, IV

Drug: Control

Interventions

Cerebrolysin DRUG

30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously

Cerebrolysin

Control DRUG

100 ml normal saline, days 4-17, once/day, IV

Control

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• Ever Neuro Pharma GmbH: collaborator

Study Sites (1)

Konkuk University Medical Center Research Coordinating Center

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 32057086 BACKGROUND

• 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.

  PMID: 22375973 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Hemorrhagic Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)