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Effects of Perampanel on Neurophysiology Test Perimeters

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ClinicalTrials.gov Identifier: NCT03653741
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Perampanel 6 MG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 12 healthy males will undergo testing, then receive the drug intervention, followed by blood draw and testing again
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Perampanel on Neurophysiology Test Perimeters
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 18, 2020
Estimated Study Completion Date : March 18, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Healthy males
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
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.
Other Name: perampanel




Primary Outcome Measures :
  1. Change in baseline visual evoked potential (P100) amplitude and latency [ Time Frame: pre-dose and post-dose of drug intake, 7 hours ]
  2. Change in baseline brainstem auditory evoked potential (waves I, III, V) amplitude and latency [ Time Frame: pre-dose and post-dose of drug intake, 7 hours ]
  3. Change in baseline somatosensory evoked potential (N20) amplitude and latency [ Time Frame: pre-dose and post-dose of drug intake, 7 hours ]
  4. Change in baseline electroencephalography background frequency content [ Time Frame: pre-dose and post-dose of drug intake, 7 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653741


Contacts
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Contact: David Chuang, M.D. 212-746-5519 dtc9002@med.cornell.edu
Contact: Peter B Forgacs, M.D. pef9015@med.cornell.edu

Locations
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United States, New York
Neurophysiology Laboratory Recruiting
New York, New York, United States, 10021
Contact: Blagovest Nikolov, M.D.    212-746-9882    bln2001@med.cornell.edu   
Principal Investigator: David Chuang, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Eisai Inc.
Investigators
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Principal Investigator: David Chuang, M.D. NYP/WCMC

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03653741    
Other Study ID Numbers: 1704018150
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes