Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
Post-Traumatic Seizure Disorder, Head Injuries
About this trial
This is an interventional treatment trial for Post-Traumatic Seizure Disorder focused on measuring neurologic and psychiatric disorders, rare disease, seizures
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Any patient developing the following conditions within 24 hour postinjury: Cortical contusion Depressed skull fracture Subdural hematoma Epidural hematoma Intracerebral hematoma Penetrating head wound Seizures occurring subsequent to head injury --Prior/Concurrent Therapy-- No antiseizure medication prior to injury or between the injury and study drug loading Surgery: No prior neurosurgical operation for which the skull and dura mater were opened --Patient Characteristics-- Age: 14 and over Hematopoietic: No abnormal coagulation profile Hepatic: No history of chronic or alcoholic liver disease Adequate liver function as indicated by ALT less than 1.5 times the upper limit of normal Other: Not pregnant No injuries greater than 24 hours old No history of seizures prior to injury No prior history of significant head injury or neurological condition requiring medical attention