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

Phase 4

Completed

• Conditions: Partial Seizures
• Interventions: Drug: Replacement with Zonisamide; Drug: Adjunctive Zonisamide

• Registration Number: NCT01630057
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-11-16
• Primary Completion: 2011-06
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Study Completion: 2012-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Replacement with Zonisamide	Replacement with Zonisamide	Patients will continue to receive zonisamide as third drug
Adjunctive Zonisamide	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.

Primary Outcome Measures

Name	Time	Method
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	13 months

Trial Locations

Locations (19)

AO Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy

AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo; 🇮🇹 Palermo, Italy

Irccs "E. Medea"; 🇮🇹 Bosisio Parini, Italy

AO Universitaria -Pisana; 🇮🇹 Pisa, Italy

AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi; 🇮🇹 Ancona, Italy

AO di Rilievo Nazionale Antonio Cardarelli; 🇮🇹 Napoli, Italy

Umberto I Policlinico di Roma; 🇮🇹 Roma, Italy

IRCCS Centro neurolesi "Bonino Pulejo" di Messina; 🇮🇹 Messina, Italy

Azienda Complesso Ospedaliero San Filippo Neri; 🇮🇹 Roma, Italy

AO Universitaria Federico II; 🇮🇹 Napoli, Italy

PO "Misericordia e dolce"-USL 4 di Prato; 🇮🇹 Prato, Italy

AO Regionale "San Carlo" di Potenza; 🇮🇹 Potenza, Italy

Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari; 🇮🇹 Cagliari, Italy

IRCCS "Eugenio Medea" Polo Scientifico di Conegliano; 🇮🇹 Conegliano, Italy

Presidio Ospedale "S.Antonio Abate di Gallarate"; 🇮🇹 Gallarate, Italy

AOU di Ferrara Arcispedale S. Anna; 🇮🇹 Ferrara, Italy

UOC Neurofisiopatologia PO S. Salvatore; 🇮🇹 L'Aquila, Italy

AO della Provincia di Lodi; 🇮🇹 Lodi, Italy

Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana; 🇮🇹 Venezia, Italy