Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy

NCT02900755 | Completed Phase 4

• 1 other identifier: 1602-107-742
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electroencephalography

Keywords

Electroencephalography; Perampanel

Outcome Measures

Primary Outcomes (1)

• Quantitative EEG (qEEG) change

  Change of qEEG markers \- spectral power: delta, theta, alpha and beta frequency band

  6th month

Secondary Outcomes (4)

• Effects on cognition

  6th month

• Effects on sleepiness

  6th month

• Effects on seizures

  6th month

• Effects on depression

  6th month

Study Arms (1)

Epilepsy

EXPERIMENTAL

Epilepsy patients (focal onset seizure with or without secondary generalization)

Drug: Perampanel

Interventions

Perampanel DRUG

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.

Also known as: Fycompa

Epilepsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Ahn SJ, Kim TJ, Cha KS, Jun JS, Byun JI, Shin YW, Sunwoo JS, Lee S, Yu KS, Jang IJ, Chu K, Lee SK, Jung KY. Effects of perampanel on cognition and quantitative electroencephalography in patients with epilepsy. Epilepsy Behav. 2021 Feb;115:107514. doi: 10.1016/j.yebeh.2020.107514. Epub 2020 Dec 14.

  PMID: 33328106 BACKGROUND

MeSH Terms

Interventions

perampanel

Study Officials

• Ki-Young Jung, M.D, Ph.D

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 14, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: November 20, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

KR (1)