The purpose of this study is to evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
This is an open labeled non-comparative, multicentric observational post marketing surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monotherapy in patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and tolerability over a 24 weeks treatment period. This study will include a total of 900 patients with partial, generalized or combined seizures across 30 centres in the country. The patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval for 24 weeks. There will be total 7 study visits and the patients will be evaluated for clinically reportable adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for efficacy by evaluation of reduction in seizure frequency as the primary objective of the study. For secondary objectives the patients data will be evaluated to determine the responder rates (\> or = to 50% reduction in seizure frequency from baseline) and seizure freedom over the 24 weeks study period.
Study Type
OBSERVATIONAL
Enrollment
655
zonisamide 100mg tablets
Unnamed facility
Hyderabad, Andhra Pradesh, India
Unnamed facility
Hyderabad, Andhra Pradesh, India
Assess safety with zonisamide therapy in adult patients with different seizure types
Time frame: 24 weeks
Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Time frame: 24 weeks
To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Time frame: 24 weeks
To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Time frame: 24 weeks
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Unnamed facility
Hyderabad, Andhra Pradesh, India
Unnamed facility
Secunderabad, Andhra Pradesh, India
Unnamed facility
Secunderabad, Andhra Pradesh, India
Unnamed facility
Vijaywada, Andhra Pradesh, India
Unnamed facility
Visakhapatnam, Andhra Pradesh, India
Unnamed facility
Visakhapatnam, Andhra Pradesh, India
Unnamed facility
Ahmedabad, Gujarat, India
Unnamed facility
Ahmedabad, Gujarat, India
...and 17 more locations