NCT04427241RecruitingPhase 4
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 3 Jun 2020
- Start date
- 1 Jun 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Konkuk University Medical Center
- Diseases
- Stroke
- NCT number
- NCT04427241
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 12
- From 1 Jun 2023 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
- Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
- Administration of a contraindicated drug is essential for medical purposes.
- Contraindications to the study drug (cerebrolysin).
Other illness
- Patients with advanced liver, kidney, cardiac, or pulmonary disease.
- 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.
- Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
Other
- Patients with confirmed epileptiform discharges on EEG
- Patients with brain parenchymal defects
- Participation in another therapeutic study
Who the study is looking for
- 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.
Age in the registry: 19 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Konkuk University Medical Center Research Coordinating Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.