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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00713622 |
Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved to treat epilepsy. The purpose of this study is to find out the extent to which zonisamide may affect memory and concentration, compared to sodium valproate.
Condition | Intervention | Phase |
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Epilepsy |
Drug: Zonisamide Drug: Sodium valproate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomised, Active Comparator, Parallel Group Study To Compare The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate |
Enrollment: | 2 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Zonisamide
Capsules of 25mg, 50mg and 100mg zonisamide will be supplied. Dosing will be twice a day.
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2: Active Comparator |
Drug: Sodium valproate
Crushable tablets of 100mg and enteric coated tablets of 200mg and 500mg will be supplied. Dosing will start at 600mg/day, increasing to the minimally effective dose, the maximum tolerated dose, or 2500mg/day, whichever is the lowest.
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Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved to treat epilepsy.
The purpose of this study is to find out the extent to which zonisamide may affect memory and concentration, compared to sodium valproate. This will be investigated using cognitive tests which are performed on a computer screen. Either zonisamide or sodium valproate will be added as a second medicine to the one patients are currently taking, carbamazepine (Tegretol), which will be continued throughout the study.
It is planned that about 80 people across Europe will take part in this study. For the purpose of the study, patients will need to go to the study doctor's clinic 4 times and have 5 telephone calls. Involvement in the study might be as long as 20 weeks, but it could be as short as 12 weeks. The length of the study and number of visits will depend on whether patients have an accurate recording of previous seizures already, how many seizures they have during the study, and whether they decide to continue or to stop treatment after the study is completed.
Adult subjects with a clinical diagnosis of non-symptomatic (i.e., idiopathic or unknown cause) localisation-related epilepsy, with partial onset seizures with or without secondary generalisation, who are receiving fixed dose carbamazepine as their only therapy or can be transferred to carbamazepine (as their only therapy) in the two months before the study baseline. Subjects must require addition of another anti-epileptic drug (AED) to their anti-epileptic therapy, either because they continue to have seizures (i.e., are not controlled), or because they wish to switch to another AED for other reasons (e.g., they tolerate another drug better).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum beta-human chorionic gonadotropin (βHCG) at screening and negative urine pregnancy test at baseline and during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception is defined here as:
Barrier contraception:
Exclusion criteria:
Austria | |
Universitae Klinik fur Neurologiet | |
Innsbruck, Austria, 6020 | |
Finland | |
Kuopio University Hospital | |
Kuopio, Finland, 70211 |
Study Director: | Andrew Yeates | Eisai Limited |
Responsible Party: | Eisai Limited ( Medical Information Department - Eisai Limited ) |
Study ID Numbers: | E2090-E044-406 |
Study First Received: | July 8, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00713622 |
Health Authority: | European Union: European Medicines Agency |
Partial onset seizures |
Epilepsy Zonisamide Seizures |
Central Nervous System Diseases Brain Diseases Valproic Acid |
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