Status:

COMPLETED

ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs

Lead Sponsor:

Eisai Inc.

Collaborating Sponsors:

Eisai Farmacêutica S.A.

Conditions:

Epilepsy

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are alread...

Detailed Description

Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the International League Against Epilepsy (ILAE) criteria, with a ...

Eligibility Criteria

Inclusion

  • Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included.

Exclusion

  • Those who do not fulfill the Inclusion requirements.

Key Trial Info

Start Date :

April 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00659958

Start Date

April 1 2008

End Date

September 1 2009

Last Update

May 13 2013

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Complejo Hospitalario Universitario 'Juan Canalejo'

A Coruña, Galicia, Spain, 15006

2

C.H. A. Marcide Profesor Novoa Santos

Ferrol, Galicia, Spain, 15405

3

Centro Sanitario Complexo Hospitalario "XERAL-CALDE"

Lugo, Galicia, Spain, 27004

4

Hospital Comarcal de Monforte

Lugo, Galicia, Spain, 27400