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

Partial Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630057
• Other study ID #: E2090-E039-401
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2010
• Last updated: July 11, 2014
• Start date: September 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partial Seizures
• Seizures

Intervention

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.
• Replacement with Zonisamide
Patients will continue to receive zonisamide as third drug

Locations

Country	Name	City	State
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	UOC Neurofisiopatologia PO S. Salvatore	L'Aquila
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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes