A Phase 4 interventional study of Zonisamide in Epilepsy, sponsored by Eisai Inc.. Completed at 11 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-13.
Sponsored by Eisai Inc. · Phase 4, Interventional, and Treatment
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.
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 32 is below the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
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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.
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.
Also known as: Zonegran
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.
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.
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Eisai Inc.