Status:
UNKNOWN
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Lead Sponsor:
Konkuk University Medical Center
Collaborating Sponsors:
Ever Neuro Pharma GmbH
Conditions:
Disorder of Consciousness
Hemorrhagic Stroke
Eligibility:
All Genders
19-120 years
Phase:
PHASE4
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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 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.
- Contraindications to the study drug (cerebrolysin).
- Participation in another therapeutic study
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04427241
Start Date
June 1 2023
End Date
December 31 2025
Last Update
May 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Konkuk University Medical Center Research Coordinating Center
Seoul, South Korea