Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Konkuk University Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Hemorrhagic Stroke; Disorder of Consciousness

Treatments: Drug: Cerebrolysin; Drug: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04427241

kuhrm2020no1

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 19 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Cerebrolysin

Experimental group

Description:

30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously

Treatment:

Drug: Cerebrolysin

Control

Placebo Comparator group

Description:

100 ml normal saline, days 4-17, once/day, IV

Treatment:

Drug: Control