Epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 12 years old, male or female; 2. Interval>24h, >=2 times, unprovoked focal seizures (with or without generalized seizures) (types of seizures refer to the classification of seizures published by ILAE in 2017); 3. Not taking antiepileptic drugs; 4. 24-hour video EEG and head MR examination within 3 months before enrollment; 5. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or allergic to the experimental drug perampanel, levetiracetam and excipients; 2. Pregnant, breastfeeding women or those who plan to become pregnant in the near future and who are unwilling to use contraceptive measures; 3. Suspect or have a history of alcohol or drug abuse; 4. Take any immunosuppressant, narcotic analgesics, and tranquilizers <=28 days before screening; 5. Patients with other mental illnesses who are unable or unwilling to cooperate; 6. Any one of the laboratory test indicators before screening meets the following criteria: admission blood routine prompts: white blood cells are less than the upper limit of the normal value (refer to the normal range of laboratory tests in the hospital); other clinically significant laboratory test abnormalities have been confirmed by the investigator. It is judged that it is not suitable to be included in the group. 7. The expected survival period is less than 3 months; 8. Diagnosis of autoimmune encephalitis within 3 months; 9. Those who have participated in other clinical trials within 3 months before enrollment; 10. The researchers believe that the patients should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure-free rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment retention time;Incidence of adverse drug reactions;Psychometric scale scores;Drug dose level of no seizure;Epileptic seizure type, type, degree; | — |
Countries
China
Contacts
The Seventh Affiliated Hospital, Sun Yat-Sen University