Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Phase 4

Not yet recruiting

• Conditions: Disorder of Consciousness; Hemorrhagic Stroke
• Interventions: Drug: Control; Drug: Cerebrolysin

• Registration Number: NCT04427241
• Lead Sponsor: Konkuk University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26
• Study Start: 2023-06-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Positron Emitting Tomography	17 days after randomization	Assessing the degree of brain neural network activity
Coma Recovery Scale - revised	17 days after randomization	Assessing the degree of disorders of consciousness

Trial Locations

Locations (1)

Konkuk University Medical Center Research Coordinating Center; 🇰🇷 Seoul, Korea, Republic of