Peramapnel First-line Monotherapy in Idiopathic Gneralized Epilepsy

JRCT ID: jRCTs031230053

Registered date:28/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic Generalized Epilepsy
• Date of first enrollment: 14/11/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Intervention for first-line drug selection

Outcome(s)

• Primary Outcome: Percentage of seizure-free after 1 year of treatment intervention

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Masuda Yosuke
• Source(s) of Monetary Support: University of Tsukuba Hospital