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

NCT01630057 | Completed Phase 4 DMC

• 1 other identifier: E2090-E039-401
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 19

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adjunctive Zonisamide

EXPERIMENTAL

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: Adjunctive Zonisamide

Replacement with Zonisamide

ACTIVE COMPARATOR

Patients will continue to receive zonisamide as third drug

Drug: Replacement with Zonisamide

Interventions

Adjunctive Zonisamide 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.

Adjunctive Zonisamide

Replacement with Zonisamide DRUG

Patients will continue to receive zonisamide as third drug

Replacement with Zonisamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• % 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (19)

UOC Neurofisiopatologia PO S. Salvatore

L’Aquila, Italy, 67100, Italy

Location

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

Ancona, 60126, Italy

Location

AO Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

Irccs "E. Medea"

Bosisio Parini, 23842, Italy

Location

Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari

Cagliari, 09124, Italy

Location

IRCCS "Eugenio Medea" Polo Scientifico di Conegliano

Conegliano, 31015, Italy

Location

AOU di Ferrara Arcispedale S. Anna

Ferrara, 44100, Italy

Location

Presidio Ospedale "S.Antonio Abate di Gallarate"

Gallarate, 21013, Italy

Location

AO della Provincia di Lodi

Lodi, 26900, Italy

Location

IRCCS Centro neurolesi "Bonino Pulejo" di Messina

Messina, 98124, Italy

Location

AO di Rilievo Nazionale Antonio Cardarelli

Napoli, 80131, Italy

Location

AO Universitaria Federico II

Napoli, 80131, Italy

Location

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

Palermo, 90127, Italy

Location

AO Universitaria -Pisana

Pisa, 56126, Italy

Location

AO Regionale "San Carlo" di Potenza

Potenza, 85100, Italy

Location

PO "Misericordia e dolce"-USL 4 di Prato

Prato, 59100, Italy

Location

Azienda Complesso Ospedaliero San Filippo Neri

Roma, 00135, Italy

Location

Umberto I Policlinico di Roma

Roma, 00161, Italy

Location

Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana

Venezia, 30174, Italy

Location

MeSH Terms

Conditions

Seizures

Interventions

Replantation; Zonisamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Salvatore Striano

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: June 28, 2012
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

IT (19)