NCT03603639

A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy

A Multicenter, Double-Blind, Randomized, Cross-Over Study Evaluating Pharmacodynamic Activity of E2730 in Adult Subjects With Photosensitive Epilepsy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to assess the pharmacodynamic (PD) activity of E2730 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with photosensitive epilepsy.

Detailed description

Adult participants with epilepsy will be enrolled in this study. This study will consist of 2 phases: Prerandomization and Randomization Phase. The Prerandomization Phase will consist of a Screening Period (up to 3 weeks), during which each participant's study eligibility will be determined and baseline assessments will be conducted. The Randomization Phase will consist of 3 Treatment Periods with a single dose in each period (placebo, E2730 40 mg, or E2730 120 mg), each separated by a 3-week washout interval for a total of approximately 6 weeks, and a Follow-up Period (3 weeks after the last dose of study drug).

Conditions

• Photosensitive Epilepsy

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive E2730-matched placebo capsule, orally.
DRUG	E2730	Participants will receive E2730 capsule, orally.

Timeline

• Start date: 2018-07-27
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2018-07-27
• Last updated: 2022-05-04
• Results posted: 2022-05-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study