A Phase 3 interventional study of phenytoin and valproate sodium in Post-Traumatic Seizure Disorder and Head Injuries, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 3, Interventional, and Treatment
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.
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 385 is above the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Any patient developing the following conditions within 24 hour postinjury:
--Prior/Concurrent Therapy--
--Patient Characteristics--
No study locations are listed for this record.
This study is completed, as verified in Dec 2001. You cannot join it, but the record below documents what was studied.
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National Institute of Neurological Disorders and Stroke (NINDS)