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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01630057
First received: November 16, 2010
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Partial Seizures
Drug: Adjunctive Zonisamide
Drug: Replacement with Zonisamide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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 [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Replacement with Zonisamide
Patients will continue to receive zonisamide as third drug
Drug: Replacement with Zonisamide
Patients will continue to receive zonisamide as third drug

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630057

Locations
Italy
AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi
Ancona, Italy, 60126
AO Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
Irccs "E. Medea"
Bosisio Parini, Italy, 23842
Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari
Cagliari, Italy, 09124
IRCCS "Eugenio Medea" Polo Scientifico di Conegliano
Conegliano, Italy, 31015
AOU di Ferrara Arcispedale S. Anna
Ferrara, Italy, 44100
Presidio Ospedale "S.Antonio Abate di Gallarate"
Gallarate, Italy, 21013
UOC Neurofisiopatologia PO S. Salvatore
L'Aquila, Italy, 67100
AO della Provincia di Lodi
Lodi, Italy, 26900
IRCCS Centro neurolesi "Bonino Pulejo" di Messina
Messina, Italy, 98124
AO di Rilievo Nazionale Antonio Cardarelli
Napoli, Italy, 80131
AO Universitaria Federico II
Napoli, Italy, 80131
AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo
Palermo, Italy, 90127
AO Universitaria -Pisana
Pisa, Italy, 56126
AO Regionale "San Carlo" di Potenza
Potenza, Italy, 85100
PO "Misericordia e dolce"-USL 4 di Prato
Prato, Italy, 59100
Azienda Complesso Ospedaliero San Filippo Neri
Roma, Italy, 00135
Umberto I Policlinico di Roma
Roma, Italy, 00161
Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana
Venezia, Italy, 30174
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Salvatore Striano Azienda Ospedaliera Universitaria Federico II
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01630057     History of Changes
Other Study ID Numbers: E2090-E039-401
Study First Received: November 16, 2010
Last Updated: July 11, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Zonisamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014