Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-120
SponsorKonkuk University Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cerebrolysin
Drug30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Control
Drug100 ml normal saline, days 4-17, once/day, IV
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: CerebrolysinExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame
2 days after randomization2
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame
17 days after randomization3
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame
2 days after randomization4
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame
17 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Konkuk University Medical Center
Lead sponsor
Ever Neuro Pharma GmbH
Collaborator
Source ClinicalTrials.gov