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A multi-center, open-label, randomized clinical trial evaluating the preventive effect of perampanel on

Junya Yamaguchi1, Fumiharu Ohka1, Kazuya Motomura1

  • 1Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan.

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Summary

This study investigates perampanel for preventing early seizures after craniotomy. Results will inform clinical practice and guidelines for seizure after craniotomy management.

Keywords:
Brain tumorEarly seizures after craniotomyPerampanelProphylaxis

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Area of Science:

  • Neurosurgery
  • Clinical Neurology
  • Pharmacology

Background:

  • Early seizures post-craniotomy are significant complications impacting patient outcomes.
  • Current guidelines lack robust evidence for routine antiseizure drug prophylaxis.
  • A discrepancy exists between guidelines and clinical practice regarding seizure prevention.

Purpose of the Study:

  • To evaluate the efficacy of perampanel in preventing early seizures following craniotomy.
  • To provide evidence-based recommendations for antiseizure drug use in this patient population.

Main Methods:

  • Multi-center, open-label, randomized clinical trial.
  • 142 seizure-naive patients with supratentorial brain tumors.
  • Perampanel (2 mg) vs. no antiseizure drugs, initiated preoperatively for 28 days postoperatively.
  • Primary outcome: incidence of seizures within 28 days post-craniotomy.

Main Results:

  • Primary outcome data collection ongoing.
  • Secondary outcomes include hospital and ICU length of stay, and postoperative complications.

Conclusions:

  • This trial is the first multi-center, randomized study on perampanel for post-craniotomy seizure prevention.
  • Findings may significantly influence clinical guidelines and perioperative care practices.
  • Addresses the critical need for evidence-based recommendations.