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Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures.

G L Krauss1, J M Serratosa, V Villanueva

  • 1Johns Hopkins University, Baltimore, MD, USA. gkrauss@jhmi.edu

Neurology
|April 21, 2012
PubMed
Summary
This summary is machine-generated.

Adjunctive perampanel significantly reduced seizure frequency in patients with partial-onset seizures. Doses of 4 and 8 mg/day demonstrated efficacy and a favorable safety profile, establishing a minimum effective dose.

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Electrophoretic Delivery of γ-aminobutyric Acid (GABA) into Epileptic Focus Prevents Seizures in Mice
07:01

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Published on: May 16, 2019

Area of Science:

  • Neurology
  • Clinical Pharmacology

Background:

  • Partial-onset seizures are a common form of epilepsy.
  • Existing antiepileptic drugs (AEDs) may not fully control seizures in all patients.

Purpose of the Study:

  • To assess the efficacy and safety of perampanel as an add-on therapy for uncontrolled partial-onset seizures.
  • To determine the optimal effective dosage of perampanel.

Main Methods:

  • A double-blind, placebo-controlled trial involving 706 patients with partial-onset seizures.
  • Patients received 1-3 concomitant AEDs and were randomized to perampanel (2, 4, or 8 mg/day) or placebo.
  • Primary endpoints included median percent change in seizure frequency and 50% responder rate.

Main Results:

  • Perampanel at 4 and 8 mg/day significantly reduced seizure frequency compared to placebo.
  • The 50% responder rates were significantly higher for perampanel 4 mg/day (28.5%) and 8 mg/day (34.9%) versus placebo (17.9%).
  • Dizziness was the most frequent adverse event, with a suggested dose-response relationship.

Conclusions:

  • Adjunctive perampanel is effective in reducing seizure frequency in patients aged 12 years and older with partial-onset seizures.
  • A minimum effective dose of 4 mg/day was established.
  • Perampanel demonstrated a favorable tolerability profile in this patient population.