Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid (VPA)
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|ClinicalTrials.gov Identifier: NCT02027987|
Recruitment Status : Unknown
Verified November 2013 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : January 6, 2014
Last Update Posted : January 6, 2014
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).
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: valproate acid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Study on the Neuroprotection and Epilepsy Prevention of Valproate Acid Administered After Severe Traumatic Brain Injury|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: valproate acid
The patients began receiving treatment at a dose of 400 mg VPA twice daily on the day after randomization by intravenous drip, with this dose continued for 14 days.The dose was increased to 500 mg twice daily at week 3 and to 400 mg three times daily at week 4 if the DRS score had not improved by at least 2 points from baseline. After the week 4 assessment, the study drug was tapered over a period of 2 to 3 days, with assessment of the patients continued through week 6. Additional procedural details are provided in the study protocol.
Drug: valproate acid
valproate acid is a common drug which is applied for epilepsy prevention and treatment.
Other Name: Sodium valproate
|Placebo Comparator: placebo|
- DRS scores [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]The DRS score includes measures of eye opening, verbalization, and motor response (derived from the Glasgow Coma Scale); cognitive understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability.
- the time of break out and state of epilepsy [ Time Frame: from 0 to 42 days when the epilepsy break out ]When the patient were admitted into the study, the breakout and the severity of epilepsy would be monitored and treated until the end of the trial.
- brain MRI scan [ Time Frame: 6 weeks after treatment ]Brain MRI scan is applied to monitor the degree and progress of the brain damage.
- the blood concentration of VPA [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]the blood was collected to detect the concentration about 2 hours after the medication of VPA
- CRS-R score [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]The CRS-R score is a standardized neurobehavioral assessment tool comprising six hierarchically organized subscales (i.e., auditory, visual, motor, oromotor-verbal, communication, and arousal); scores range from 0 to 23, with higher scores indicating a higher level of neurobehavioral function.
- function of kidney [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety.
- function of liver [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]There are several main indicators including ALT, AST, Tbil, D-bil, I-bil, ALB,GLB, and ALP, and so on. These indicators could monitor the change of liver function in case of liver damage.
- Physiological and pathological reflex check [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]
- muscular strength and tension test [ Time Frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study ]There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
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): NCT02027987
|Contact: Hu S Jie, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Hu S Jie, M.D., Ph.D.||086 email@example.com|
|Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University||Recruiting|
|Xi'an City, Shaanxi, China, 710032|
|Contact: Hu S Jie, M.D., Ph.D. 086 029 84773307 firstname.lastname@example.org|
|Contact: Fei Zhou, M.D., Ph.D. 086 029 13992888996 email@example.com|
|Principal Investigator: Hu S Jie, M.D., Ph.D.|
|Study Director:||Fei Zhou, M.D., Ph.D.||Institute of Neurosurgery, Xijing Hospital, Fourth Military Medical University|