Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy
Condition: Electroencephalography
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Perampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment
      of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective
      non-competitive antagonist of AMPA receptors.

      Evaluating adverse effects during the introduction of new AED is often difficult since the
      complaints are subjective and objective assessment is complicated due to the polytherapy.
      Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs
      because of the correlation of EEG analysis results and side effects of AED such as cognitive
      slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms
      of EEG background spectra and to evaluate perampanel effects by using subjective
      questionnaires assessing depression, anxiety, sleep quality and fatigue.
    

Detailed description: 
      Perampanel is a selective antagonist of the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic
      acid (AMPA) receptor and is used to treat partial-onset seizures with or without secondary
      generalization. This antiepileptic drug (AED) is usually prescribed as adjunctive treatment
      and is also used primarily in generalized tonic-clonic seizures Cognitive dysfunction is a
      major comorbidity in many patients with epilepsy and could be the result of chronic use of
      AEDs. Since cognitive decline has a tremendous impact on the quality of life, the effect of a
      large number of AEDs on cognition has been actively studied. It has been reported that AEDs
      such as gabapentin, carbamazepine, and topiramate induce cognitive decline, while
      lamotrigine, levetiracetam, and oxcarbazepine show much less negative effect on cognitive
      function compared with the older AEDs. Perampanel has also been studied for its effects on
      cognition in adolescent patients with epilepsy aged 12-18 years. However, the effects of
      perampanel on cognitive function have not yet been studied in adults.

      Electroencephalogram (EEG) spectral analysis or quantitative EEG (QEEG) is a method of
      quantifying the different frequencies in EEG signals. Spectral analysis of EEG frequency can
      reflect the functional state of the brain. Thus, it has proved to be a useful tool for
      assessing the pharmacological effects of central nervous system (CNS) drugs.
      Electrophysiologic changes due to AEDs can manifest as either a generalized slowing of or an
      increased beta frequency on EEG in general. Changes in background EEG may be correlated with
      clinical cognitive function. Since EEG changes in the spectral analysis are only intended to
      assess brain activity and do not directly reflect clinical changes in patients,
      neuropsychological (NP) tests are necessary for evaluating clinical cognitive function. Our
      objective was to determine how perampanel affects cognition and the EEG signal in adult
      patients with epilepsy. Correlation of these effects was also analyzed with the serum
      concentration of perampanel.
    

Intervention name(s): Perampanel
Intervention type(s): Drug
Intervention description(s): The subjects will be administered oral perampanel for six months. Dose will be titrated according to the tolerance and be maintained at least 1 month before second EEG evaluation.
Other intervention name(s): Fycompa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Electroencephalography; Perampanel