Levetiracetam to Prevent Post-Traumatic Epilepsy

This is an interventional prevention trial for Epilepsy focused on measuring Post-Traumatic epilepsy, Traumatic brain injury, Epilepsy prevention, Levetiracetam Read More

Inclusion Criteria:

• Acute head injury associated with one of the following:

Intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; Penetrating (foreign body) head injury; Skull fracture and dural tear; Seizure within 8 hours of head injury

• Onset of head injury within 8-hours of proposed treatment initiation.
• Glasgow Coma Scale 6-15.

Exclusion Criteria:

• Clinical contraindications:

  • Previous epilepsy or status epilepticus.
  • Any systemic illness or unstable medical condition that might pose additional risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer.
  • Psychosis within six months of enrollment as determined by history of hospitalization for psychosis or medications for psychosis.
  • Moderate to severe mental retardation (IQ< 55 or>2 school grade levels below the expected for age [expected age = grade level +5]).

• Clinical/Laboratory Indicators:

  • Serum creatinine > 1.5 on the day of treatment initiation for adults.
  • Serum creatinine ≥1.5 for subjects ≥17 years old, ≥1.0 for subjects 13-17 years old and ≥0.7 for subjects 6-12 years old.
  • Pregnancy
  • Use of any CNS-active investigational drugs within 3 months of enrollment.
  • Use of Antiepileptic Drugs (AEDs) within two months of enrollment, for any indication.
  • Allergy/sensitivity to study drugs or their formulations:
  • Active drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements:
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.