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Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Konkuk University Medical Center Research Coordinating Center
RECRUITING
Seoul
Contact Information
Primary
Jongmin Lee, M.D., Ph.D.
jongminleemd@gmail.com
+821063558073
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Cerebrolysin
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Placebo_comparator: Control
100 ml normal saline, days 4-17, once/day, IV
Related Therapeutic Areas
Sponsors
Collaborators: Ever Neuro Pharma GmbH
Leads: Konkuk University Medical Center

This content was sourced from clinicaltrials.gov