A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies

Phase 2 Completed 141 enrolled Takeda Healx AI · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.

Timeline

Start: 2018-08-08
Primary completion: 2020-06-09
Completion: 2020-07-20

Outcome

Met primary endpoint

paper ELEKTRA achieved its primary endpoint: the combined soticlestat-treated population demonstrated a placebo-adjusted median reduction in seizure frequency of 30.21% during the maintenance period PMID 35841234 ↗

registry analysis (superiority test); Placebo vs TAK-935; p = 0.0007; Hodges-Lehmann Estimation -30.48 (95% CI -46.99 to -13.19) NCT03650452 ↗

release “The ELEKTRA study achieved its primary endpoint with high statistical significance, demonstrating a 27.8% median reduction from baseline” takeda.com ↗

Publications

Hahn CD, Jiang Y, Villanueva V, Zolnowska M, Arkilo D, Hsiao S, Asgharnejad M, Dlugos D. A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA). Epilepsia. 2022 Oct;63(10):2671-2683. doi: 10.1111/epi.17367. Epub 2022 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Soticlestat	Small molecule	600 mg	Oral