Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
1. Background:
Preliminary studies have suggested that valproate acid (VPA) may promote neuron
survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia,
and promote the brain functional recovery after traumatic brain injury (TBI). Besides,
in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the
antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than
7 days).
2. Objectives:
Our main objective was to evaluate whether VPA could protect brain and improve recovery
of brain function after severe TBI. The secondary objective was to explore whether VPA
could prevent late epilepsy after severe TBI (more than 7 days).
3. Methods:
We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16
weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly
assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the
treatment was discontinued. The rate of functional recovery on the Disability Rating Scale
(DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the
4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of
mixed-effects regression models.