Idiopathic Generalized Epilepsy
Conditions
Interventions
Intervention for first-line drug selection
Sponsors
Masuda Yosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 12 years of age or older (2) Idiopathic generalized epilepsy (myoclonic, absence, or tonic-clonic seizures confirmed by interview and consistent with idiopathic generalized epilepsy on EEG) (3) Patients who have obtained written consent from the patient or a surrogate
Exclusion criteria
Exclusion criteria: (1) Patients over 80 years of age (2) Patients with moderate or severe renal dysfunction (eGFR<60 mL/min/1.73 m2 ) (3) Patients with hepatic dysfunction of moderate severity or greater (AST or ALT greater than 2.5 times the upper limit of the reference value or total bilirubin greater than 1.5 times the upper limit of the reference value) (4) Complications of non-epileptic psychogenic seizures (if the patient has a history of epileptic seizures, patients without psychogenic seizures for more than 2 years are not excluded) (5) Patients with complications of other epilepsy syndromes such as focal epilepsy and unclassifiable epilepsy (6) Acute symptomatic seizures (e.g., convulsive seizures caused by head trauma, stroke, or encephalitis) (7) History of epileptic seizures (8) History of severe drug allergy (9) Inability of the patient or family member to keep an observation diary (10) Female patients of childbearing potential who cannot use an acceptable method of contraception (11) Female patients who are pregnant (or planning to become pregnant) or lactating (12) Patients with a history of serious adverse reactions to perampanel (13) Patients who have been treated with antiepileptic drugs for more than 8 days (14)Patients who are deemed inappropriate as research subjects by the investigator or others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of seizure-free after 1 year of treatment intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percentage of seizures resolved 1 year after reaching the final dose 2) Percentage of seizure reduction per month (myoclonic, absence, tonic-clonic seizures), 80% responder, 50% responder 3) Scalp EEG (30 min) changes 1) Number of epileptic abnormal waves (spiny wave, slow wave) (abnormal background activity) (ii) Changes in background activity Distribution, frequency change 4) Drug continuation rate 5) Incidence of side effects (acceptable and unacceptable side effects) 6) Changes in sleep assessment (Pittsburgh Sleep Questionnaire) 7) Changes in higher functional assessment (Epitrack) 8) Changes in the Self-Rated Depression Scale (SDS) 9) Pharmacokinetics and safety evaluation | — |
Contacts
Public ContactYosuke Masuda
University of Tsukuba Hospital
Outcome results
None listed