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Tests treatment safety and results for Disorder of Consciousness
Official title Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
ClinicalTrials.gov ID: NCT04427241
What this study is testing
What is Cerebrolysin?
Cerebrolysin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for disorder of consciousness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 120
You may be able to join 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 likely can't join 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...
- Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
See the full eligibility criteria
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.