NCT02900755

Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Electroencephalography

Interventions

Type	Name	Description
DRUG	Perampanel	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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-04-01
• Completion: 2020-11-20
• First posted: 2016-09-14
• Last updated: 2021-09-29

Locations

1 site across 1 country: South Korea