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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
Sponsor:
Information provided by (Responsible Party):
Ki-Young Jung, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Electroencephalography Drug: Perampanel Phase 4

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Epilepsy
Epilepsy patients (focal onset seizure with or without secondary generalization)
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.




Primary Outcome Measures :
  1. Quantitative EEG (qEEG) change [ Time Frame: 6th month ]

    Change of qEEG markers

    - spectral power: delta, theta, alpha and beta frequency band



Secondary Outcome Measures :
  1. 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

  2. Effects on sleepiness [ Time Frame: 6th month ]

    Clinical questionnaire

    - Epworth Sleepiness Scale


  3. Effects on seizures [ Time Frame: 6th month ]
    Seizure frequency per month

  4. Effects on depression [ Time Frame: 6th month ]
    BDI (Beck Depression Index)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ki-Young Jung, M.D, Ph.D +82-2-2072-4988 jungky10@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Young Jung, professor    +82-2-2072-0694    jungky10@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Ki-Young Jung, M.D, Ph.D Seoul National University Hospital

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Responsible Party: Ki-Young Jung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02900755     History of Changes
Other Study ID Numbers: 1602-107-742
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Keywords provided by Ki-Young Jung, Seoul National University Hospital:
Electroencephalography
Perampanel
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases