A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502281-25-00

Acronym

XPF-010-302

Enrollment

197

Registered

2023-05-12

Start date

2023-09-27

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Onset Seizures

Brief summary

Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo

Detailed description

MPC in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo, Proportion of subjects experiencing ≥50% reduction in weekly (7 days) focal seizure frequency from baseline to Week 1., Proportion of subjects experiencing “at least much improved” (including “much” and “very much improved”) in PGIC at Week 12.

Interventions

DRUGXPF-010

DRUGXEN1101 placebo drug product consists of a size 3 white opaque HPMC capsule (Capsugel VCaps® Plus White OP) containing 10mg of Avicel® PH102 (microscrystaline cellulose)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo	—

Secondary

Measure	Time frame
MPC in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo, Proportion of subjects experiencing ≥50% reduction in weekly (7 days) focal seizure frequency from baseline to Week 1., Proportion of subjects experiencing “at least much improved” (including “much” and “very much improved”) in PGIC at Week 12.	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026