Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
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|ClinicalTrials.gov Identifier: NCT00004817|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Seizure Disorder Head Injuries||Drug: phenytoin Drug: valproate sodium||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||385 participants|
|Study Start Date :||February 1991|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004817
|Study Chair:||H. Richard Winn||Harborview Injury Prevention and Research Center|