Clinical trial NCT00659958: ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: zonisamide
partial onset seizures
effectiveness
tolerability
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eisai Farmacêutica S.A.
First posted: 2008-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of seizures.
timeFrame: Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.
Secondary outcomes:
measure: Quality of life, tolerability.
timeFrame: 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.
Other outcomes:
Locations:
city: Coruna
country: Spain
facility: Complejo Hospitalario Universitario 'Juan Canalejo'
state: Galicia
city: Ferrol
country: Spain
facility: C.H. A. Marcide Profesor Novoa Santos
state: Galicia
city: Lugo
country: Spain
facility: Centro Sanitario Complexo Hospitalario "XERAL-CALDE"
state: Galicia
city: Lugo
country: Spain
facility: Hospital Comarcal de Monforte
state: Galicia
city: Lugo
country: Spain
facility: Centro Sanitario Hospital Da Costa de Burela
state: Galicia
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
state: Galicia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago de Compostela
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro
state: Galicia
city: Vigo
country: Spain
facility: Hospital Povisa
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies
state: Galicia
Study officials:
affiliation: EISAI Farmaceutica S.A. Head of Medical Department
name: Jesus De Rosendo
role: STUDY_CHAIR
References: