drugset / Trial / NCT03686033

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

NCT03686033 ↗

Phase 2 Terminated 8 enrolled Eisai Inc.
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2018-10-31
Primary completion
2019-06-18
Completion
2019-06-18

Outcome

Met primary endpoint

Stopped: “Safety Review”

registry analysis (superiority test); Treatment A: Placebo vs Treatment C: E2082 25 mg; LS Mean difference -4.17 (90% CI -6.35 to -1.99) NCT03686033 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject E2082 Unknown 2.5 mg Oral
Subject E2082 Unknown 25 mg Oral
Subject E2082 Unknown 40 mg Oral