Epilepsy
Conditions
Interventions
experimental group:Perampanel tablets
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects older than or equal to 12 years old, male or female; 2. Patients who met the criteria for focal seizures in the International League of epilepsy classification (ilae1981); 3. Subjects who need additional treatment after failure of monotherapy with the best dosage and course of treatment; 4. Patients who are currently receiving stable dose monotherapy (standard antiepileptic drugs) for at least 8 weeks, and have only used 1-2 AEDs within 8 weeks; 5. The patients who had been treated with antiepileptic drugs in the past 8 weeks still had focal seizures, and the average number of seizures was more than 2 times / month, and the interval between seizures was more than 24 hours.
Exclusion criteria
Exclusion criteria: 1. Pregnant (ß - hCG positive) or lactating women; 2. Patients with primary generalized epilepsy or seizures such as absence and / or myoclonic seizures; 3. Patients with a history of status epilepticus within 12 weeks before enrollment; 4. Patients with unstable recurrent affective disorder who are using antipsychotics or have mental illness or suicide attempt within one year before enrollment; 5. Patients with progressive central nervous system diseases include degenerative central nervous system diseases and patients with progressive tumors; 6. Patients who used barbiturates (except anticonvulsant therapy and EEG) and benzodiazepines (except anticonvulsant therapy) in the first 8 weeks of the study; 7. Patients with benzodiazepines more than or equal to 2 times were treated intermittently within 8 weeks before admission; 8. Patients with moderate to severe kidney disease or receiving hemodialysis; 9. Patients with severe liver diseases; 10. Patients allergic to the drug or ingredient; 11. Patients with rare genetic diseases such as lactose intolerance, lactose deficiency or glucose lactose absorption disorder; 12. Patients participating in other clinical trials; 13. Those subjects that the researcher thinks are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% treatment response rate of all seizures in the maintenance phase (within 9-32 weeks after the first treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| 100% treatment response rate for all seizures;Percentage of subjects still using perampanel 5 months and 8 months after the first treatment;The percentage of changes in the frequency of seizures during the titration period and maintenance period from baseline;50% response rate to treatment in subjects with secondary generalized tonic-clonic seizures;100% treatment response rate in subjects with secondary generalized tonic-clonic seizures;Relative to the baseline period, the change in the proportion of the frequency of secondary tonic-clonic seizures during the titration period and the maintenance period; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital of Capital Medical University
Outcome results
None listed