Effects of Perampanel on Neurophysiology Test Perimeters

NCT03653741 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1704018150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Change in Baseline Visual Evoked Potential (P100) Amplitude

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Visual Evoked Potential (P100) Latency

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Brainstem Auditory Evoked Potential (Waves I, III, V) Amplitude

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Brainstem Auditory Evoked Potential (Waves I, III, V) Latency

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Somatosensory Evoked Potential (N20) Amplitude

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Somatosensory Evoked Potential (N20) Latency

  pre-dose and post-dose of drug intake, 7 hours

• Change in Baseline Electroencephalography Background Frequency Content

  pre-dose and post-dose of drug intake, 7 hours

Study Arms (1)

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

Drug: Perampanel 6 MG

Interventions

Perampanel 6 MG DRUG

Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.

Also known as: perampanel

Healthy males

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Eisai Inc.: collaborator

Study Sites (1)

Neurophysiology Laboratory

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

perampanel

Results Point of Contact

• Title: David Chuang, MD
• Organization: Weill Cornell Medical College

dtc9002@med.cornell.edu

212-746-5519

Study Officials

• David Chuang, M.D.

  NYP/WCMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12 healthy males will undergo testing, then receive the drug intervention, followed by blood draw and testing again

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)