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

A Randomized Trial of Preventive Effect on Craniotomy-Induced EpileptoGenesis by PERAMPANEL in Seizure-Naive Patients with Supratentorial Brain Tumor - GRAMPAS trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230117
Enrollment
142
Registered
2023-12-18
Start date
2023-12-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumor

Interventions

Taking 2mg of perampanel tablets for 2 days before surgery and for 28 days after surgery or observation

Sponsors

Saito Ryuta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence rate of seizures within 28 days after surgery

Secondary

MeasureTime frame
Length of hospital stay, Length of ICU stay, Adverse events, Postoperative complications

Contacts

Public ContactShoichi Deguchi

Nagoya University Graduate School of Medicine

deguchi.shoichi.z9@f.mail.nagoya-u.ac.jp+81-52-744-2353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026