Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug

Overview

An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.

Full Title of Study: “An Open-label, Randomized, Multi-centre, Superiority Study to Compare, in Patients With Partial Onset Seizures, the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: Adjunctive Zonisamide
    • Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.
  • Drug: Replacement with Zonisamide
    • Patients will continue to receive zonisamide as third drug

Arms, Groups and Cohorts

  • Experimental: Adjunctive Zonisamide
    • Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.
  • Active Comparator: Replacement with Zonisamide
    • Patients will continue to receive zonisamide as third drug

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy
    • Time Frame: 13 months

Participating in This Clinical Trial

Patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven't obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months. Inclusion criteria:

  • Age ≥ 18 years; – Patients with non progressive localization-related epilepsy; – Patients who are able and willing to give written Informed Consent; – Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide; – 50% or greater seizure reduction* as assessed after an at least three-month maintenance period with zonisamide. – = seizure frequency before starting zonisamide must be documented checking case histories. Exclusion criteria:

  • Patients contraindicated for zonisamide use (see SmPC); – Patients with renal or hepatic impairment; – Pregnant or lactating women; – Women of childbearing age who are not willing to use any contraceptive method with established efficacy. – Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation; – Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency; – Patients who have been on an investigational drug or device within 30 days prior to the initiation of the present study; – Patients with a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Salvatore Striano, Principal Investigator, Azienda Ospedaliera Universitaria Federico II

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