Focal epilepsy
Conditions
Interventions
observation group:Pirentanil, once a day
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be admitted to this program. 1. Age 4-12 years, male or female; 2. According to the 2017 International Union Against Epilepsy (ILAE) Seizure and Epilepsy Classification Standards, recently diagnosed with focal seizures or focal progression to bilateral tonic-clonic seizures, and confirmed by EEG results; 3. Have at least 1 seizure in the 3 months prior to presentation; 4. Have not used any ASMs before (except short-term epilepsy emergency treatment); 5. Suitable for perampanel monotherapy by the doctor.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be admitted to this program: 1. There is a serious structural, genetic metabolic cause or a clear diagnosis of epileptic encephalopathy; 2. Severe organ dysfunction; 3. Are taking antipsychotic drugs, have a history of mental illness, or have suicidal thoughts or behaviors; 4. Known allergy to perampanel active ingredient and lactose; 5. Are participating in other clinical trials; 6. Those who the investigator believes that the follow-up cannot be completed on time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants without seizures after perampanel treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retention of perampanel monotherapy at different time points during treatment visits;During the treatment visit, the proportion and duration of patients who have been seizure-free for 3 consecutive months were achieved;The proportion of patients whose seizure frequency decreases at different time points during treatment visits;Proportion of seizure-free secondary generalized tonic-clonic seizures at different time points during treatment visits;During the treatment visit, secondary generalized tonic-clonic seizures were 50% and 75% response rates at different time points;During the treatment visit, the starting and maintenance doses of perampanel and the proportion of participants who achieved 50%, 75%, and 100% response rates at different maintenance doses;During treatment visits, perampanel achieved 50%, 75%, and 100% response rates at different ages;Safety and tolerability of monotherapy in children with perampanel; | — |
Countries
China
Contacts
Public ContactYuwu Jiang
Peking University First Hospital
Outcome results
None listed