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
Qualifiers
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
Treatments tested in this trial
- Cerebrolysin
- Control
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Konkuk University Medical Center
Lead sponsor
Ever Neuro Pharma GmbH
Collaborator
Source ClinicalTrials.gov