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

NCT ID: NCT01630057

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Partial Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adjunctive Zonisamide

Intervention Type: DRUG

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.

Replacement with Zonisamide

Patients will continue to receive zonisamide as third drug

Group Type: ACTIVE_COMPARATOR

Replacement with Zonisamide

Intervention Type: DRUG

Patients will continue to receive zonisamide as third drug

Interventions

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.

Intervention Type: DRUG

Replacement with Zonisamide

Patients will continue to receive zonisamide as third drug

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Striano

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

UOC Neurofisiopatologia PO S. Salvatore

L’Aquila, Italy, Italy

AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi

Ancona, , Italy

AO Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Irccs "E. Medea"

Bosisio Parini, , Italy

Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari

Cagliari, , Italy

IRCCS "Eugenio Medea" Polo Scientifico di Conegliano

Conegliano, , Italy

AOU di Ferrara Arcispedale S. Anna

Ferrara, , Italy

Presidio Ospedale "S.Antonio Abate di Gallarate"

Gallarate, , Italy

AO della Provincia di Lodi

Lodi, , Italy

IRCCS Centro neurolesi "Bonino Pulejo" di Messina

Messina, , Italy

AO di Rilievo Nazionale Antonio Cardarelli

Napoli, , Italy

AO Universitaria Federico II

Napoli, , Italy

AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo

Palermo, , Italy

AO Universitaria -Pisana

Pisa, , Italy

AO Regionale "San Carlo" di Potenza

Potenza, , Italy

PO "Misericordia e dolce"-USL 4 di Prato

Prato, , Italy

Azienda Complesso Ospedaliero San Filippo Neri

Roma, , Italy

Umberto I Policlinico di Roma

Roma, , Italy

Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana

Venezia, , Italy

Countries

Italy

Other Identifiers

E2090-E039-401

Identifier Type: -

Identifier Source: org_study_id