Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury.

II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Collaborator: Harborview Injury Prevention and Research Center
• Treatments: Phenytoin; Valproic Acid

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