Clinical Trial Details
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NCT02027987 : Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid
PhasePhase 1
AgesMin: 16 Years Max: 65 Years
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

- All the patients had provided written informed consent.

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

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.
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