Effects of Perampanel on Neurophysiology Test Perimeters

Weill Medical College of Cornell University1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2018年10月1日最近更新: 2023年7月3日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Weill Medical College of Cornell University
入组人数: 12
试验地点: 1
主要终点: Change in Baseline Visual Evoked Potential (P100) Amplitude

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a study to evaluate the effects of perampanel, a FDA approved drug for epilepsy, on commonly performed neurophysiology tests: electroencephalogram (EEG), somatosensory evoked potential (SEP), brainstem auditory evoked potential (BAEP), and visual evoked potential (VEP). Many other drugs used in the treatment of epilepsy have been shown to affect the results of these test but no one has yet examined if perampanel affects these tests. The investigators plan to recruit 12 healthy normal male subjects. All subjects will have VEP, SSEP, EEG, and BAER performed before and 1 hour (when Cmax is reached) after receiving 6mg of oral perampanel. Subjects will also receive a blood draw 1 hour after ingestion of perampanel for serum perampanel level. In a previous study done at another institution, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well. There is no placebo nor randomization. Subject's participation concludes after completion of post-perampanel ingestion neurophysiology tests.

详细描述

The study drug used in this research study is perampanel, an FDA approved medication for the treatment of seizures. The study is being done to examine whether the study drug affects the following non-invasive tests of brain activity: electroencephalogram (EEG), visual evoked potential (VEP), brainstem auditory evoked potential (BAER), and somatosensory evoked potential (SEP). Many anti-seizure drugs have been shown to affect these 4 tests. Anti-seizure medications such as phenytoin, carbamazepine, and oxcarbazepine have been shown to cause slowing of brain activity on EEGs. To date, there have been no published data on whether perampanel, affects EEG, VEP, SEP, or BAER. The data from this study may help with interpretation of these tests in epileptic patients on perampanel.

The investigators are looking for male participants with no prior chronic medical conditions to partake in this study.

All participants will undergo the following tests as part of the study:

EEG: this test monitors the electrical activity of the brain through small, metal disks (electrodes) that are placed on the scalp. The test is painless and after the electrodes are placed, participants will be asked to lay down as brain activity is monitored.
VEP: this test is similar to the EEG in that electrodes will be placed on the back of the head to monitor brain electrical activity. This test looks specifically at what is happening in the part of the brain that responds to vision, so during the test participants will be shown visual stimuli like a bright light or image on a screen to stimulate brain activity.
BAER: this test is similar to the EEG in that electrodes will be placed on participant's head to monitor brain electrical activity. This test looks specifically at what is happening in the part of the brain that responds to sound, so during the test, different sounds will be played to stimulate brain activity.
SEP: this test is similar to the EEG in that electrodes will be placed on participant's head to monitor brain electrical activity. This test looks specifically at what is happening in the part of the brain that responds to touch and body sensations, so electrodes will also be placed on the arms and legs to stimulate that area with an electric pulse. This electrical stimulation can cause mild discomfort but is generally well tolerated. Participants may feel muscles twitch when the electrical stimulation is given.

These tests are non-invasive and done routinely in the evaluation of neurologic diseases. They are well tolerated and have no long term side effects.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy subjects between the ages of 18 to 50 years old with a body mass index of 19-29 kg/m2 will be recruited.

排除标准

•Subjects would be excluded if they use recreational drugs and have any neurologic disease, psychiatric condition or any other condition that may affect outcome and risk subject safety. Furthermore, anyone that would not be able to participate in neurophysiology tests will also be excluded. Subject will also be excluded should they take any over the counter medication or consume caffeine or alcohol 12 hours prior to the study.

研究组 & 干预措施

Healthy males

Experimental

healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time

干预措施: Perampanel 6 MG (Drug)