Combination Treatment With Cerebrolysin and Amantadine on Patients Who Stays in Prolonged Disorders of Consciousness Due to Severe Traumatic Brain Injury

• Status: Not yet recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Object: To demonstrate the combined effect of cerebrolysin and amantadine on prolonged disorders of consciousness in patients with severe traumatic brain injury Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury Intervention: amantadine only (100mg to 200mg bid) or cerebrolysin only (30ml qd) or amantadine (100mg to 200mg bid) plus cerebrolysin (30ml qd) Comparison: amantadine only group versus cerebrolysin only group versus amantadine plus cerebrolysin group Outcome: Coma Recovery Scale-revised, FDG-PET signal

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborator: Ever Neuro Pharma GmbH
• Treatments: Amantadine; Cerebrolysin

Criteria

Inclusion Criteria:

• Patient with Severe traumatic brain injury (GCS ≤8, best available score within 24hrs)

• TBI Confirmed with CT or MRI

• at least 4 weeks after traumatic event

• vegetative state or minimally conscious state secondary to TBI (assessed by CRS-R)

• Patient between 19 and 64 years of age

• Written informed consent obtained from the patient or legally authorized representative

Exclusion Criteria:

• with epileptiform discharge confirmed by EEG

• with hydrocephalus

• with parenchymal defect

• with advanced liver, kidney, cardiac or pulmonary disease

• with history of advanced cancer within 2 years

• history of alcohol or substance abuse or dependence within the past two years (DSM-V criteria)

• any significant systemic illness (or unstable medical condition that could lead to difficulties complying with the protocol

• history of treatment with antidepressants, antipsychotic drugs, nootropic drugs, vasodilators

• contraindication from amantadine or cerebrolysin

• current enrolment in another therapeutic study