Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy

Summary

This is a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study with cross-over to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients with Drug Resistant Epilepsy

Timeline

Start

2020-10-30

Primary completion

2023-12

Completion

2023-12

Outcome

Mixed primary results

paper Overall, based on seizure diaries, participants had 68%-80% improvement in seizure frequency on ES-481 treatment, compared with 38%-49% on placebo treatment (p = 0.097). PMID 42312676 ↗

paper For the highest dose of ES-481 treatment (75 mg bid), subjects had 80% improvement (90% confidence interval [Cl] 43%-97%), while participants on placebo for the corresponding week had 49% improvement (90% Cl 1%-74%) (p = 0.047). PMID 42312676 ↗

paper There was no significant difference in the reduction of seizure frequency at the lower ES-481 treatment doses. PMID 42312676 ↗

Publications

• Foster EC, Millist L, Germaine J, Chamorro S, Roberts C, Nicolo JP, Hosking S, Perucca P, Mullen S, Robinson H, Wharrie R, Walsh B, Reutens D, Irwin K, Zeng H, Niecestro R, O'Brien TJ. A first in disease trial of the safety, tolerability, and anti-seizure effects of ES-481 in drug-resistant epilepsy. Epilepsia Open. 2026 Jun 18. doi: 10.1002/epi4.70294. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ES-481	Unknown	75 mg	—

Indications