Trial · Interventional

RecruitingPhase 4Registry data

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

NCTNCT04427241Other idkuhrm2020no1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 12 participants (estimated)
Sponsor: Konkuk University Medical Center · Other
Design: Randomized · Quadruple masking
Countries: 1 country
South Korea
Start: 1 Jun 2023
Primary completion: 30 Sept 2026 (estimated)
Completion: 31 Dec 2026 (estimated)
First posted: 11 Jun 2020
Last update posted: 11 May 2026
Conditions: Disorder of Consciousness · Hemorrhagic Stroke

Timeline

1 trial · 1 ongoing

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

20232024202520262027

Ph 4
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
NCT04427241
1 Jun 2023 to est. 31 Dec 2026

Registry summary

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

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

Interventions

CerebrolysinDrug
ControlDrug

Arms2

Experimental
Cerebrolysin
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Placebo comparator
Control
100 ml normal saline, days 4-17, once/day, IV

Primary outcomes4

Outcomes the sponsor listed as primary.

Coma Recovery Scale - revised
Time frame · 2 days after randomization
Registry description
Assessing the degree of disorders of consciousness
Coma Recovery Scale - revised
Time frame · 17 days after randomization
Registry description
Assessing the degree of disorders of consciousness
Positron Emitting Tomography
Time frame · 2 days after randomization
Registry description
Assessing the degree of brain neural network activity
Positron Emitting Tomography
Time frame · 17 days after randomization
Registry description
Assessing the degree of brain neural network activity

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2020

3 results

Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study.

Lee et al. 2020Journal of rehabilitation medicinecited by 7

PMID 32057086DOI 10.2340/16501977-2654PUB-32057086

Full text at the publisher3 results

Publisher page See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 120 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria 1. Patients with hemorrhagic stroke confirmed by CT or MRI 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 1. Patients with confirmed epileptiform discharges on EEG 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

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