A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Phase 2 Active not recruiting 325 enrolled Xenon Pharmaceuticals Inc. Novotech Health Holdings Pte. Ltd. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

Timeline

Start: 2019-01-30
Primary completion: 2021-09-02
Completion: 2028-10

Outcome

Met primary endpoint

paper The median (IQR) percent reduction from baseline in monthly FOS frequency was 52.8% (P < .001 vs placebo; IQR, -80.4% to -16.9%) for 25 mg PMID 37812429 ↗

release “On October 4, 2021, Xenon announced that the X-TOLE trial had met its primary efficacy endpoint” xenon-pharma.com ↗

release “The X-TOLE topline efficacy data demonstrated that the primary and secondary seizure reduction endpoints were statistically significant across all three dose groups” xenon-pharma.com ↗

release “X-TOLE met the primary and key secondary efficacy endpoints with XEN1101 demonstrating a statistically significant, dose-dependent reduction” xenon-pharma.com ↗

Publications

Results French JA, Porter RJ, Perucca E, Brodie MJ, Rogawski MA, Pimstone S, Aycardi E, Harden C, Qian J, Rosenblut CL, Kenney C, Beatch GN; X-TOLE Study Group. Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy: A Phase 2b Randomized Clinical Trial. JAMA Neurol. 2023 Nov 1;80(11):1145-1154. doi: 10.1001/jamaneurol.2023.3542.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azetukalner	Small molecule	10 mg	Oral
Subject	Azetukalner	Small molecule	20 mg	Oral
Subject	Azetukalner	Small molecule	25 mg	Oral