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19-014 - A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Status: open

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy

Treatment for Epilepsy

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Description

The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 4-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the duration of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening.

Providers Associated With This Trial

Principle Investigator

Sub Investigators

  • Juan OchoaView Profile
    Juan G. Ochoa, M.D.NeurologistDirector of the Neurology Residency Program; Director of the SouthCEP Comprehensive Epilepsy Center; Professor of Neurology
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