NCT04427241 Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
| NCT ID | NCT04427241 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Konkuk University Medical Center |
| Condition | Disorder of Consciousness |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 12 participants in total. It began in 2023-06-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04427241 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 120 Years, studying Disorder of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04427241 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04427241 currently recruiting?
Yes, NCT04427241 is actively recruiting participants. Contact the research team at jongminleemd@gmail.com for enrollment information.
Where is the NCT04427241 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT04427241 clinical trial?
NCT04427241 is sponsored by Konkuk University Medical Center. The trial plans to enroll 12 participants.