A Phase 1 interventional study of valproate acid in Traumatic Brain Injury, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-06.
Sponsored by Xijing Hospital · Phase 1, Interventional, and Prevention
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).
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).
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.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's planned enrollment of 160 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Sodium valproate
DRS scores
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.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
the time of break out and state of epilepsy
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.
Time frame: from 0 to 42 days when the epilepsy break out
brain MRI scan
Brain MRI scan is applied to monitor the degree and progress of the brain damage.
Time frame: 6 weeks after treatment
the blood concentration of VPA
the blood was collected to detect the concentration about 2 hours after the medication of VPA
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
CRS-R score
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.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
function of kidney
There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
function of liver
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.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
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
There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
Time frame: On the 0,7th,14th,21st,28th,35th,42nd days since admitted into the study
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Xijing Hospital