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

Primary Purpose

Partial Seizures

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Adjunctive Zonisamide
Replacement with Zonisamide
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Seizures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi
  • AO Universitaria Consorziale Policlinico di Bari
  • Irccs "E. Medea"
  • Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari
  • IRCCS "Eugenio Medea" Polo Scientifico di Conegliano
  • AOU di Ferrara Arcispedale S. Anna
  • Presidio Ospedale "S.Antonio Abate di Gallarate"
  • UOC Neurofisiopatologia PO S. Salvatore
  • AO della Provincia di Lodi
  • IRCCS Centro neurolesi "Bonino Pulejo" di Messina
  • AO di Rilievo Nazionale Antonio Cardarelli
  • AO Universitaria Federico II
  • AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo
  • AO Universitaria -Pisana
  • AO Regionale "San Carlo" di Potenza
  • PO "Misericordia e dolce"-USL 4 di Prato
  • Azienda Complesso Ospedaliero San Filippo Neri
  • Umberto I Policlinico di Roma
  • Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjunctive Zonisamide

Replacement with Zonisamide

Arm Description

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.

Patients will continue to receive zonisamide as third drug

Outcomes

Primary Outcome 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

Secondary Outcome Measures

Full Information

First Posted
November 16, 2010
Last Updated
July 11, 2014
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01630057
Brief Title
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjunctive Zonisamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Replacement with Zonisamide
Arm Type
Active Comparator
Arm Description
Patients will continue to receive zonisamide as third drug
Intervention Type
Drug
Intervention Name(s)
Adjunctive Zonisamide
Intervention Description
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
Intervention Name(s)
Replacement with Zonisamide
Intervention Description
Patients will continue to receive zonisamide as third drug
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Striano
Organizational Affiliation
Azienda Ospedaliera Universitaria Federico II
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
AO Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Irccs "E. Medea"
City
Bosisio Parini
ZIP/Postal Code
23842
Country
Italy
Facility Name
Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
IRCCS "Eugenio Medea" Polo Scientifico di Conegliano
City
Conegliano
ZIP/Postal Code
31015
Country
Italy
Facility Name
AOU di Ferrara Arcispedale S. Anna
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Presidio Ospedale "S.Antonio Abate di Gallarate"
City
Gallarate
ZIP/Postal Code
21013
Country
Italy
Facility Name
UOC Neurofisiopatologia PO S. Salvatore
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
AO della Provincia di Lodi
City
Lodi
ZIP/Postal Code
26900
Country
Italy
Facility Name
IRCCS Centro neurolesi "Bonino Pulejo" di Messina
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
AO di Rilievo Nazionale Antonio Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AO Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
AO Universitaria -Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
AO Regionale "San Carlo" di Potenza
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
PO "Misericordia e dolce"-USL 4 di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Azienda Complesso Ospedaliero San Filippo Neri
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Umberto I Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana
City
Venezia
ZIP/Postal Code
30174
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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