Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy

• Status: Completed
• Trial end date: 2020-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

Inclusion Criteria:

• Male or female subjects aged 18-65 years

• Provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the IRB guidelines

• Subjects in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations including demonstration of normal renal function.

• Patient with focal-onset seizures with or without secondary generalized seizure

• History of epilepsy for at least 2 years.

• The subject must have had an EEG or clinical seizure consistent with partial epilepsy.

Exclusion Criteria:

• A history of non-epileptic or psychogenic seizures.

• Women who are pregnant or lactating.

• Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study.

• Liver transammases (AST and ALT) cannot exceed twice the upper limit of normal and total and direct bilirubin must be within normal limits.

• An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.

• Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the subject's ability to participate in the study.

• Suffering from psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; subject with current major depressive episode (or within 6 months).

• A history of alcoholism, drug abuse, or drug addiction within the past 2 years.

• History of regular alcohol consumption exceeding 2-3 units/day for females and 3-4 units/day for males

• History of regular use of tobacco or nicotine-containing products exceeding the equivalent of 5 cigarettes per day

• History of regular consumption of caffeine exceeding the equivalent of 4 cups of coffee per day, a level that approximates health-related criteria

• Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.

• Subjects with more than 1 lifetime suicide attempt or any suicide attempt within the past two years.