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Effects of Perampanel on Neurophysiology Test Perimeters

Clinical Trial Details

This is a study to evaluate the effects of perampanel, an 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 tests, 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, SEP, EEG, and BAEP performed before and 1 hour after receiving 6mg of oral perampanel. Subjects will also receive a blood draw 1 hour after ingestion of perampanel.

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.

Key Eligibility: 

  

Inclusion Criteria:

  • Healthy male subjects with a body mass index of 19-29 kg/m2
  • Age 18 to 50 years old


   Exclusion Criteria:

  • Participants cannot use recreational drugs or have any neurologic disease or psychiatric condition.
  • Those unable to participate in neurophysiology tests will also be excluded.
  • Subjects cannot ingest any over-the-counter medication or consume caffeine or alcohol 12 hours prior to the study. 

Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Seyhmus Aydemir
212-746-5538
sea4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1704018150

ClinicalTrials.gov:

NCT03653741

Status

Open to Enrollment

Age Group

Adult

Sponsor