NCT04427241

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 120 Years
• Healthy volunteers: Not accepted

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

Conditions

• Disorder of Consciousness
• Hemorrhagic Stroke

Interventions

Type	Name	Description
DRUG	Cerebrolysin	30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
DRUG	Control	100 ml normal saline, days 4-17, once/day, IV

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2020-06-11
• Last updated: 2023-05-26

Locations

1 site across 1 country: South Korea