drugset / Trial / NCT03603639

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

NCT03603639 ↗

Phase 2 Terminated 6 enrolled Eisai Inc.
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2018-07-27
Primary completion
2019-02-14
Completion
2019-02-14

Outcome

Missed primary endpoint

Stopped: “The study was stopped due to efficacy reasons.”

registry analysis (superiority test); Treatment A: Placebo vs Treatment B: E2730 40 mg; LS Mean difference 1.38 (90% CI -0.72 to 3.48) NCT03603639 ↗

registry analysis (superiority test); Treatment A: Placebo vs Treatment C: E2730 120 mg; LS Mean difference 1.07 (90% CI -0.49 to 2.63) NCT03603639 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject E2730 Unknown 40 mg Oral
Subject E2730 Unknown 120 mg Oral