Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness (NCT04427241) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
South Korea12 participantsStarted 2023-06-01
Plain-language 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
Who can participate
Age range
19 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
. Patients with confirmed epileptiform discharges on EEG
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.