A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules
matching placebo
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period
Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.
Time frame: Baseline and Month 4
Percentage of Responders During Last 28 Days of Maintenance Period
Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.
Time frame: Baseline and Month 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinik und Polyklinik fur Epileptologie
Bonn, Germany
Georg-August-Universiat Gottingen
Göttingen, Germany
Asklepiosklinik Barmbek
Hamburg, Germany
Clinical Research Hamburg
Hamburg, Germany
ZNS Hamburg
Hamburg, Germany
Universitaet Giessen / Marburg
Marburg, Germany
Neurologische
Siegen, Germany
Semmelweis University - Neurology Dept.
Budapest, Hungary
Synexus Magyarorszag Kft.
Budapest, Hungary
National Institute of Neurosurgery
Budapest, Hungary
...and 26 more locations