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

• ClinicalTrials.gov Identifier: NCT00659958
• Recruitment Status: Completed
• First Posted: April 17, 2008
• Last Update Posted: May 13, 2013
• Sponsor: Eisai Inc.
• Collaborator: Eisai Farmacêutica S.A.
• Information provided by (Responsible Party): Eisai Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: Zonisamide	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

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 Name: Zonegran

Outcome Measures

Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Complejo Hospitalario Universitario 'Juan Canalejo'

Coruna, Galicia, Spain, 15006

C.H. A. Marcide Profesor Novoa Santos

Ferrol, Galicia, Spain, 15405

Centro Sanitario Complexo Hospitalario "XERAL-CALDE"

Lugo, Galicia, Spain, 27004

Hospital Comarcal de Monforte

Lugo, Galicia, Spain, 27400

Centro Sanitario Hospital Da Costa de Burela

Lugo, Galicia, Spain, 27880

Complejo Hospitalario de Ourense

Ourense, Galicia, Spain, 32005

Complejo Hospitalario de Pontevedra

Pontevedra, Galicia, Spain, 36071

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, Galicia, Spain, 15706

Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro

Vigo, Galicia, Spain, 36204

Hospital Povisa

Vigo, Galicia, Spain, 36211

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

Vigo, Galicia, Spain, 63204

Sponsors and Collaborators

Eisai Inc.

Eisai Farmacêutica S.A.

Investigators

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

More Information

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00659958
• Other Study ID Numbers: E2090-E044-407
• First Posted: April 17, 2008
• Last Update Posted: May 13, 2013
• Last Verified: March 2010

Keywords provided by Eisai Inc.:

zonisamide; partial onset seizures; effectiveness; tolerability

Additional relevant MeSH terms:

Seizures; Nervous System Diseases; Neurologic Manifestations; Zonisamide; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs