Efficacy & Safety of Zonisamide in newly diagnosed partial epilepsy patients.
Phase 3
Completed
- Conditions
- ewly diagnosed partial epilepsyNewly diagnosed partial epilepsyNeurological - Epilepsy
- Registration Number
- ACTRN12607000142437
- Lead Sponsor
- Eisai Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 583
Inclusion Criteria
Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clincially evaluated and calssified partial seizures or generalized tonic-clonic seizures within 12 months of screening.
Exclusion Criteria
Subjects have a history of clinical investigations, including EEG data. Subjects with a history of absence, myoclonic, clonic, tonic or atonic seizures, subjects currently taking carbonic anhydrase inhibitors, mono amine oxidase inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects remaining seizure free for at least a 26 week period when treated with zonisamide or carbamazepine as compared to baseline.[ Seizure diary will be measured at every visit from week 1 to week 56]
- Secondary Outcome Measures
Name Time Method Proportion of subjects seizure free for 52 weeks. [ Seizure diary will be reviewed at every Visit from week 3 to between week 31 to week 103. Time to withdrawal due to lack of efficacy/due to an Adverse Events from week 3 to between week 31 to 109. Time to the start of a 26 weeks and 52 week seizure free period. For this the seizure diary will be measured between week 31 and 109 and at week 109.]