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

NCT00659958 | Completed Phase 4

• 1 other identifier: E2090-E044-407
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 11

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.

Conditions

Epilepsy

Keywords

zonisamide; partial onset seizures; effectiveness; tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

Drug: Zonisamide

Interventions

Zonisamide DRUG

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.

Also known as: Zonegran

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Farmacêutica S.A.: collaborator

Study Sites (11)

Complejo Hospitalario Universitario 'Juan Canalejo'

A Coruña, Galicia, 15006, Spain

Location

C.H. A. Marcide Profesor Novoa Santos

Ferrol, Galicia, 15405, Spain

Location

Centro Sanitario Complexo Hospitalario "XERAL-CALDE"

Lugo, Galicia, 27004, Spain

Location

Hospital Comarcal de Monforte

Lugo, Galicia, 27400, Spain

Location

Centro Sanitario Hospital Da Costa de Burela

Lugo, Galicia, 27880, Spain

Location

Complejo Hospitalario de Ourense

Ourense, Galicia, 32005, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, Galicia, 36071, Spain

Location

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro

Vigo, Galicia, 36204, Spain

Location

Hospital Povisa

Vigo, Galicia, 36211, Spain

Location

Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies

Vigo, Galicia, 63204, Spain

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jesus De Rosendo

  EISAI Farmaceutica S.A. Head of Medical Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 13, 2013

Record last verified: 2010-03

Locations

ES (11)