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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 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 12 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-11-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03653741
The ClinicalTrials.gov registry entry for NCT03653741 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Perampanel 6 MG is the first listed.
NCT03653741 reports 0 study locations.
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.
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