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|NCT02027987 : Traumatic Neuroprotection and Epilepsy Prevention of Valproate Acid|
|Ages||Min: 16 Years Max: 65 Years|
- 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
- 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
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02027987
| Link to official Clinicaltrials.gov listing