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A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy

A Multicenter, Double-Blind, Randomized, Crossover, Single-Dose Study With An Open-Label Treatment Period Evaluating Pharmacodynamic Activity of E2082 in Adult Subjects With Photosensitive Epilepsy

NCT03686033•Eisai Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to assess pharmacodynamic (PD) activity of E2082 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with photosensitive epilepsy, compared to placebo.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis and/or history of a PPR on EEG.
•2. If currently being treated with antiepileptic drug (AED), up to a maximum of 3 concomitant AEDs is allowed provided that doses must have remained stable for at least 4 weeks (or at least 8 weeks if recently initiated) before screening.
•3. Reproducible IPS-induced PPR on EEG of at least 3 points on the SPR scale in at least 1 eye condition (eye closure, eyes closed, eyes open) on at least 3 of the EEGs performed at screening.
•4. Body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m\^2) (inclusive) and a total body weight greater than or equal to (\>=) 45 kilogram (kg) at screening.
•5. Agrees to refrain from strenuous exercise and alcohol consumption during the 24-hour period before screening and before each treatment day.

Exclusion Criteria

•1. Females who are breastfeeding or pregnant at screening or baseline.
•2. Male participants who have not had a successful vasectomy, they and their female partners not of childbearing potential, or practicing highly effective contraception throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation.
•3. History of nonepileptic seizures (example, metabolic, structural, or pseudoseizures) while on any antiepileptic medication.
•4. History of status epilepticus while on any antiepileptic medication(s) within 2 years before screening.
•5. Ongoing or history of generalized tonic-clonic seizures (GTCS) within 6 months before screening.
•6. Participants who had developed a clinical seizure during previous PPR assessment, or who experiences a clinical seizure during the Screening IPS procedure.
•7. Frequent spontaneous background burst or current evidence of proconvulsive activity on EEG (example, increase in spike-wave activity) at screening.
•8. Inability to follow restriction on watching television, or use of any device(s) with an animated screen (example, computer, video games, tablets, or smart phone) from the time of arrival at the study center until study procedures are completed for that day.
•9. Use of perampanel within 6 weeks before screening.
•10. Use of felbamate for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1.
+10 more criteria

Locations (5)

Clinical Trials, Inc. and Arkansas Epilepsy Program

Little Rock, Arkansas, United States

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States

Johns Hopkins University- School of Medicine

Baltimore, Maryland, United States

Washington University Hospital

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

October 31, 2018

Primary Completion Date

June 18, 2019

Completion Date

June 18, 2019

Last Updated

September 28, 2020

Enrollment

ACTUAL participants

Conditions

Photosensitive Epilepsy

Interventions

Placebo

DRUG

E2082

DRUG

Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).

NCT03790137

Photosensitive Epilepsy

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Effect of Valproic Acid Concentration on Photic Response

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Photosensitive Epilepsy

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COMPLETEDPHASE2

Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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