MedTrace Logo

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

NCT00004817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Post-Traumatic Seizure Disorder
  • Head Injuries

Interventions

DRUG

phenytoin

DRUG

valproate sodium

Sponsors & Collaborators

  • Harborview Injury Prevention and Research Center

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • H. Richard Winn · Harborview Injury Prevention and Research Center

Study Design

Purpose
TREATMENT

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004817 on ClinicalTrials.gov