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Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid

Information source: Xijing Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: valproate acid (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Xijing Hospital

Official(s) and/or principal investigator(s):
Fei Zhou, M.D., Ph.D., Study Director, Affiliation: Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Overall contact:
Hu S Jie, M.D., Ph.D., Phone: 086-29-84773307, Email: hushijie@fmmu.edu.cn


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: DRS scores

Secondary outcome:

the time of break out and state of epilepsy

brain MRI scan

the blood concentration of VPA


Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Eligible patients were 16 to 65 years of age with all genders.

- The patients had sustained a nonpenetrating traumatic brain injury 4 to 16 weeks

before enrollment, with the confirmation of CT or MRI.

- Additional eligibility criteria were a vegetative state or a minimally conscious

state, as indicated by a Disability Rating Scale (DRS) score greater than 11.

- There was an inability both to follow commands consistently and to engage in

functional communication, as assessed by the score on the Coma Recovery Scale-Revised (CRS-R)

- All the patients had provided written informed consent.

- The patients were receiving usual inpatient rehabilitation and treatment at each

site. Exclusion Criteria:

- unstable health state,including: Be allergic to VPA, or with serious allergic diseases

or allergic constitutions;With serious cardiovascular diseases, hepatic, renal, or psychiatric diseases;With serious respiratory, endocrine, or blood system diseases;With serious infections or malignant tumors; With weakened immunologic status;Addison's diseases;With alcohol or drug abuse.

- Any disability related to the central nervous system that predated the traumatic

brain injury.

- Pregnancy or breastfeeding females.

- More than one seizure in the previous month.

- Prior treatment with VPA

- In the case of patients who were undergoing evaluation for ventricular shunt

placement or receiving a psychoactive medication, enrollment was deferred until shunt placement had been completed or psychoactive medications discontinued.

- The patients had enrolled the other studies in the past three months or are engaging

the other studies.

- The patients were assessed as unqualified for the study according to the

comprehensive evaluation opinion brought forward by the research team.

Locations and Contacts

Hu S Jie, M.D., Ph.D., Phone: 086-29-84773307, Email: hushijie@fmmu.edu.cn

Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an City, Shaanxi 710032, China; Recruiting
Hu S Jie, M.D., Ph.D., Phone: 086 029 84773307, Email: hushijie@fmmu.edu.cn
Fei Zhou, M.D., Ph.D., Phone: 086 029 13992888996, Email: feizhou@fmmu.edu.cn
Hu S Jie, M.D., Ph.D., Principal Investigator
Additional Information

Starting date: October 2013
Last updated: January 2, 2014

Page last updated: August 20, 2015

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