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

May 9, 2013 updated by: Eisai Inc.

Post-authorization, Observational and Prospective Follow up Study to Evaluate Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs

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 already being treated with two other antiepileptic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 minimum of two seizures 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 in the study.

To these patients, physicians will prescribe zonisamide in the following manner: Titration period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable.

Drugs will be prescribed by the physician and purchased by the patient.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Galicia
      • Coruna, Galicia, Spain, 15006
        • Complejo Hospitalario Universitario 'Juan Canalejo'
      • Ferrol, Galicia, Spain, 15405
        • C.H. A. Marcide Profesor Novoa Santos
      • Lugo, Galicia, Spain, 27004
        • Centro Sanitario Complexo Hospitalario "XERAL-CALDE"
      • Lugo, Galicia, Spain, 27400
        • Hospital Comarcal de Monforte
      • Lugo, Galicia, Spain, 27880
        • Centro Sanitario Hospital Da Costa de Burela
      • Ourense, Galicia, Spain, 32005
        • Complejo Hospitalario de Ourense
      • Pontevedra, Galicia, Spain, 36071
        • Complejo Hospitalario de Pontevedra
      • Santiago de Compostela, Galicia, Spain, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
      • Vigo, Galicia, Spain, 36204
        • Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro
      • Vigo, Galicia, Spain, 36211
        • Hospital Povisa
      • Vigo, Galicia, Spain, 63204
        • Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

Those who do not fulfill the Inclusion requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Zonisamide
300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.
Other Names:
  • Zonegran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of seizures.
Time Frame: Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.
Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life, tolerability.
Time Frame: Quality of Life evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks have passed. Tolerability will be assessed at the beginning of the study (enrollment visit) and at 12, 18, and 24 weeks.
Quality of Life evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks have passed. Tolerability will be assessed at the beginning of the study (enrollment visit) and at 12, 18, and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Collaborators

Eisai Farmacêutica S.A.

Investigators

  • Study Chair: Jesus De Rosendo, EISAI Farmaceutica S.A. Head of Medical Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2090-E044-407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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