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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Zonisamide

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




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. ]


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659958


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 Farmaceutica, S.A.
Investigators
Study Chair: Jesus De Rosendo EISAI Farmaceutica S.A. Head of Medical Department

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00659958     History of Changes
Other Study ID Numbers: E2090-E044-407
First Posted: April 17, 2008    Key Record Dates
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
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs