Traumatic Brain Injury contusion, acute subdural hematoma, acute epidural hematoma, traumatic subarchnoid hemorrhage, diffuse axional injury
Conditions
Interventions
Randomly assign one of the following:
Intervention Group (Perampanel Group): Administer oraly 2 mg/day of perampanel within 12 hours of TBI diagnosis. The administration is once daily for 7 days.
Co
C551441, C043114
Perampanel, Fosphenytoin, Anti-epileptic drug
Sponsors
Yamamoto Ryo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years or older Traumatic brain injury (TBI) including contusion, acute subdural hematoma, acute epidural hematoma, traumatic subarchnoid hemorrhage, and diffuse axional injury is diagnosed with CT or MRI Glasgow Coma Scale is 9 - 14 on hospital arrival or at the time of TBI diagnosis Consent for study participation is obtained Trial medications can be administered per oral
Exclusion criteria
Exclusion criteria: Patients with epilepsy as a comorbidity Patients who arrive at the hospital more than 24 hours after injury Patients with an Injury Severity Score of 25 or higher Pregnant patients Patients with contraindication for Perampanel administration Patients with contraindication for Fosphenytoin administration Patients deemed unsuitable for the study by the research physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equal to or more than 5 of GOSE score at 90 days after TBI diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| GOSE score at 90 days after TBI diagnosis MMSE score at 90 days after TBI diagnosis Traumatic epilepsy seizures up to 90 days Adverse events up to 90 days GOSE score at 30 days Traumatic epilepsy seizures up to 30 days Hospital-, ICU-, and Ventilator-free days up to 30 days Traumatic epilepsy seizures and adverse events up to 7 days | — |
Contacts
Public ContactRyo Yamamoto
Keio University Hospital
Outcome results
None listed