NCT02027987

Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid

Clinical Study on the Neuroprotection and Epilepsy Prevention of Valproate Acid Administered After Severe Traumatic Brain Injury

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	valproate acid	valproate acid is a common drug which is applied for epilepsy prevention and treatment.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-01-06
• Last updated: 2014-01-06

Locations

1 site across 1 country: China