A trial to evaluate the preventive effect on craniotomy-induced epileptogenesis by perampanel

JRCT ID: jRCTs041230117

Registered date:18/12/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Brain tumor
• Date of first enrollment: 18/12/2023
• Target sample size: 142
• Study type: Interventional
• Intervention(s): Taking 2mg of perampanel tablets for 2 days before surgery and for 28 days after surgery or observation

Outcome(s)

• Primary Outcome: Incidence rate of seizures within 28 days after surgery
• Secondary Outcome: Length of hospital stay, Length of ICU stay, Adverse events, Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients with supratentorial brain tumor scheduled for craniotomy
Patients who meet any of the following
Intraaxial tumors
Extraaxial tumors with brain edema
Extraaxial tumors without brain edema compress the motor cortex and are judged by the surgeon to be at high risk for the development of seizures early after brain surgery

KPS over 70
18 to 80 years old
No history of epilepsy
No contraindications for use of perampanel
Written consent has been obtained from the individual or a surrogate

Exclude criteria

Patients who have difficulty taking tablets orally
Patients indicated for awake surgery
Patients with central nervous system diseases other than brain tumors
Patients with a history of treatment for central nervous system diseases
Patients with a history of taking antiepileptic drugs other than perampanel within 1 week of surgery
Other patients in which the physician deems the applicant unsuitable for enrollment in the relevant study

Related Information

• Primary Sponsor: Saito Ryuta