Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre, Randomised, Active Comparator, Parallel Group Study To Compare The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate|
- Percent change from Baseline in 28-day seizure frequency at Week 12; response rate at 12 weeks. [ Time Frame: Change from baseline to Week 12 in the Computerised Visual Searching Task Reaction Time (CVST) from the Ferum Psyche (FePsy) cognitive battery, which measures central information processing speed conducted at visits 2, 5 and 8. ] [ Designated as safety issue: No ]
- Safety will be assessed by the incidence of AEs and serious adverse events (SAEs); incidence of withdrawal for treatment emergent adverse events (TEAEs); physical and neurological examinations. [ Time Frame: Visits 1 and Visit 8; vital signs and weight conducted at Visits 1,2,5 and 8; clinical laboratory tests Visit 1 and 8. ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Capsules of 25mg, 50mg and 100mg zonisamide will be supplied. Dosing will be twice a day.
Other Name: Zonegran
|Active Comparator: 2||
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.
Other Name: Epilim
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713622
|Universitae Klinik fur Neurologiet|
|Innsbruck, Austria, 6020|
|Kuopio University Hospital|
|Kuopio, Finland, 70211|
|Study Director:||Andrew Yeates||Eisai Limited|