The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.


PROTOCOL OUTLINE: This is a randomized, double blind trial involving 3 treatment groups. On day 1, controls receive phenytoin IV over 1 hour. On days 2 through 7, controls receive 2 doses each of phenytoin and placebo daily, intravenously. From day 8 through 6 months, controls receive placebo IV 4 times daily, then placebo tablets are administered. On day 1, the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury. Then, patients are divided into 2 subgroups. From day 2 through 1 month, one group of patients receives valproate IV 4 times daily over 1 hour until tablets are tolerated. Patients receive placebo tablets by mouth 4 times daily from month 2 through month 6. On day 2, the other group of patients receives valproate IV 4 times daily and continues for 6 months until tablets (same dose) are tolerated. If patients remain seizure free between day 8 and 6 months, the number of valproate or placebo tablets are tapered over 1 week. Each patient receives a full neuropsychological and psychosocial examination at 1, 6, and 12 months after injury. Untreated observation of patients continues until 2 years after injury.

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

Study Design: