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NCT03653741 · ClinicalTrials.gov registry record · Phase 4

Effects of Perampanel on Neurophysiology Test Perimeters

A Phase 4 study, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
Phase 4
Development phase
12
Enrollment target

NCT03653741: Completed Phase 4 study, sponsored by Weill Medical College of Cornell University.

NCT03653741 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03653741, a Phase 4 study, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
Phase 4
Development phase
12 participants
Enrollment target

Study 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.

Interventions

  • DRUG Perampanel 6 MG

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2018-10-01
Est. Completion 2021-11-29
Phase Phase 4

What the finished NCT03653741 record still lists

NCT03653741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Perampanel 6 MG is the first listed.

NCT03653741 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03653741 about?

NCT03653741 is a clinical study titled "Effects of Perampanel on Neurophysiology Test Perimeters". 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...

What is the current status of trial NCT03653741?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2018-10-01. Estimated completion is 2021-11-29.

What interventions are being tested in trial NCT03653741?

The interventions under investigation include: Perampanel 6 MG (DRUG).

Who is sponsoring clinical trial NCT03653741?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03653741's enrollment target sits among peer trials

12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03653741, the US trial registry maintained by the National Library of Medicine. NCT03653741 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.