Drug-resistant epilepsy in adults
Conditions
Interventions
Experimental group:Clobazam tablets
Control group:placebo
Sponsors
The Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Any of the following criteria would result in exclusion from the study: (1) Failure to meet the 2010 international alliance of antiepileptic drug refractory epilepsy diagnosis standard, which requires appropriate selection and proper utilization of at least two well-tolerated antiepileptic drugs, either as monotherapy or in combination therapy, without achieving a seizure-free interval exceeding three times the maximum seizure duration prior to treatment initiation or one year. The eligible seizure types include focal seizures, bilateral tonic-clonic seizures, and generalized seizures. (2) Age between 18 and 65 years with no gender restrictions. (3) Stable use of 1-3 antiepileptic drugs for a minimum period of four weeks before enrollment into the study; retrospective observation during this period should reveal an average frequency of at least four epileptic seizures every four weeks (excluding single-day cluster attacks). Once enrolled, any changes in medication regimen should be avoided unless necessitated by breakthrough seizures. (4) No recent usage of benzodiazepines other than temporary emergency administration within the first three months; participation in other clinical trials involving medications is also not permitted during this time frame. (5) Informed consent must be obtained from patients themselves or their legal guardians.
Exclusion criteria
Exclusion criteria: The subjects who were unable to attend the test due to any of the following reasons were considered as "yes": (1) patients with a cultural level below junior middle school or brain damage, who cannot comprehend and complete research-related forms and refused to participate; (2) individuals with progressive central nervous system diseases or intracranial infections causing seizures; (3) those suffering from severe heart and lung diseases (such as acute myocardial infarction, angina, coronary heart disease, heart failure, pulmonary embolism, respiratory failure, lung cancer, brain tumor, brain edema, hydrocephalus), Parkinson's disease, Alzheimer's disease motor neuron disease), metabolic disorders (such as brain mitochondrial myopathy, hyperthyroidism or hypothyroidism, benzene acetone urine), peripheral neuropathy and neuromuscular junction diseases; abnormal laboratory biochemical indicators, including white blood cells coun,t red blood cells count, platelets count, hemoglobin concentration, electrolyte levels, ALT, AST, urea, creatinine, total bilirubin, direct bilirubin, ECG serious abnormalities; (4) individuals with a history of alcohol or drug addiction/abuse; (5) pregnant or lactating women and women/men planning pregnancy during the follow-up period; (6) individuals known to have allergies to benzodiazepines chlorides or any component of the study drugs leading to central nervous system activity-induced mental behavior changes; (7) taking barbiturates except for emergency cases where temporary use is allowed); (8) individuals with severe mental disorders/history of suicide attempts; (9) professionals engaged in specific occupations such as drivers, high-altitude operators, machine operators etc.;(10) participants deemed unsuitable by researchers involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of seizures in patients decreased by over 50%.;Median reduction in seizure frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life 31 scale score for adult epileptic patients;Electrocardiograph;Chest X-ray;Adverse event recording; | — |
Countries
China
Contacts
Public ContactZhou Liemin
The Seventh Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed