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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659958
• Other study ID #: E2090-E044-407
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2008
• Last updated: May 9, 2013
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario 'Juan Canalejo'	Coruna	Galicia
Spain	C.H. A. Marcide Profesor Novoa Santos	Ferrol	Galicia
Spain	Centro Sanitario Complexo Hospitalario "XERAL-CALDE"	Lugo	Galicia
Spain	Centro Sanitario Hospital Da Costa de Burela	Lugo	Galicia
Spain	Hospital Comarcal de Monforte	Lugo	Galicia
Spain	Complejo Hospitalario de Ourense	Ourense	Galicia
Spain	Complejo Hospitalario de Pontevedra	Pontevedra	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 Universitario de Vigo (CHUVI), Hospital Xeral-Cies	Vigo	Galicia
Spain	Hospital Povisa	Vigo	Galicia

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Eisai Farmaceutica, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes