Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy
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|ClinicalTrials.gov Identifier: NCT02900755|
Recruitment Status : Unknown
Verified December 2016 by Ki-Young Jung, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : September 14, 2016
Last Update Posted : December 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Electroencephalography||Drug: Perampanel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||August 2017|
Epilepsy patients (focal onset seizure with or without secondary generalization)
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.
- Quantitative EEG (qEEG) change [ Time Frame: 6th month ]
Change of qEEG markers
- spectral power: delta, theta, alpha and beta frequency band
- Effects on cognition [ Time Frame: 6th month ]global cognitive function: Mini-mental state examination Attention and working memory: Digit span forward and backward Frontal/Executive function: Stroop test, trail-making test (TMT, A -and B types), Controlled Oral Word Association test (COWA) Visuospatial function: Rey complex figure test Language: Short form of K-BNT Memory: The Korean version of the California Verbal Learning Test (KCVLT) for verbal memory and the Rey complex figure test of visual memory
- Effects on sleepiness [ Time Frame: 6th month ]
- Epworth Sleepiness Scale
- Effects on seizures [ Time Frame: 6th month ]Seizure frequency per month
- Effects on depression [ Time Frame: 6th month ]BDI (Beck Depression Index)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900755
|Contact: Ki-Young Jung, M.D, Ph.Demail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Ki-Young Jung, professor +82-2-2072-0694 firstname.lastname@example.org|
|Study Director:||Ki-Young Jung, M.D, Ph.D||Seoul National University Hospital|