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

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: Zonisamide

• Registration Number: NCT00659958
• Lead Sponsor: Eisai Inc.

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 already being treated with two other antiepileptic drugs.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-03
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zonisamide	-

Primary Outcome Measures

Name	Time	Method
Frequency of seizures.	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

Name	Time	Method
Quality of life, tolerability.	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.

Trial Locations

Locations (11)

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Galicia, Spain

Complejo Hospitalario Universitario 'Juan Canalejo'; 🇪🇸 Coruna, Galicia, Spain

Centro Sanitario Complexo Hospitalario "XERAL-CALDE"; 🇪🇸 Lugo, Galicia, Spain

C.H. A. Marcide Profesor Novoa Santos; 🇪🇸 Ferrol, Galicia, Spain

Hospital Comarcal de Monforte; 🇪🇸 Lugo, Galicia, Spain

Centro Sanitario Hospital Da Costa de Burela; 🇪🇸 Lugo, Galicia, Spain

Complejo Hospitalario Universitario Santiago de Compostela; 🇪🇸 Santiago de Compostela, Galicia, Spain

Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro; 🇪🇸 Vigo, Galicia, Spain

Complejo Hospitalario de Ourense; 🇪🇸 Ourense, Galicia, Spain

Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies; 🇪🇸 Vigo, Galicia, Spain

Hospital Povisa; 🇪🇸 Vigo, Galicia, Spain