epilepsy
Conditions
Interventions
Experimental group:parempanel additive therapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=12 years, no gender limit; 2. Conform to the classification criteria for seizure types in the International Epilepsy Federation Classification of Seizures (2005); 3. On the basis of other antiepileptic drug treatment, patients who have been treated with perampanel for at least 8 weeks; 4. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant patients (positive beta-hCG test) or lactating patients; 2. Primary generalized epilepsy or seizures, such as absence and/or myoclonic seizures; 3. Those who have a history of status epilepticus within 12 weeks before enrollment; 4. Those with unstable recurrent affective disorder who are using antipsychotic drugs or have mental illness or have attempted suicide within one year before enrollment; 5. After taking perampanel, mental and behavioral adverse reactions such as aggressiveness, hostility, irritability, anger, murderous thoughts and threats are obvious; 6. Long-term alcohol abuse patients, that is, men drink more than three units per day or women drink more than two units of standard alcohol per day, and each unit of standard alcohol is about 250 mL of beer, 100 mL of wine or 30 mL of spirits; 7. Patients with progressive central nervous system diseases, including degenerative central nervous system diseases and progressive tumors; 8. Concomitant use of barbiturates (except for anticonvulsant therapy and EEG premedication) and benzodiazepines (except for anticonvulsant therapy) within 8 weeks before enrollment; 9. Intermittent use of rescue benzodiazepines for more than or equal to 2 times within 8 weeks before enrollment; 10. Moderate to severe renal disease or those receiving hemodialysis (creatinine clearance =12 mg/day; 15. Those who are participating in other clinical trials; 16. The researcher thinks it is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| parempanel plasma concentration;other antiepileptic drugs concentration;proportion of patients with 50% or more effective response to treatment and complete seizure control at 12 months;electroencephalogram;whether there are adverse events;CYP3A4/5 genotype;GRIA1-4 genotype; | — |
Secondary
| Measure | Time frame |
|---|---|
| hematological and biochemical tests;changes in the frequency of various seizures compared to baseline;electrocardiogram; | — |
Countries
China
Contacts
Public ContactWu Xunyi
Huashan Hospital, Fudan University
Outcome results
None listed