Effects of Perampanel on Neurophysiology Test Perimeters

• Status: Recruiting
• Trial end date: 2023-03-17
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Eisai Inc.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.