Randomized trial to assess efficacy and safety of an add-on treatment with zonisamide in adults with focal epileptic seizures with or without secondary generalizatio

Conditions: Partial epileptic seizures with or without secondary generalisation
MedDRA version: 7.1Level: PTClassification code 10040703

Registration Number: EUCTR2005-000260-57-DE

Lead Sponsor: Eisai GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

oAdult aged between 18 years and 74 years
oFocal epileptic seizures with or without secondary generalization
oPresent treatment with one or two antiepileptic drugs (constant dosage during the 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
oAt least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 weeks prospective or retrospective baseline phase
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oEpileptic state during the past year
oNon-epileptic fits
oGeneralized epilepsy
oConcomitant progressive CNS disease including progressive myoclonus epilepsy
oConcomitant treatment with vigabatrine and/or topiramate
oHepatic and/or renal insufficiency (creatinine > 2 mg% or GPT > 2 times ULN)
oBody weight less than 40 kg
o(History of) kidney stones; erythrocyturia; family history (in parents, children, brothers and sisters or grandparents) of kidney stones
o(History of) drug and/or alcohol dependence
oActive psychosis
oSuicide attempt during the past 3 years
oPre-treatment with zonisamide
oKnown hypersensitivity to sulfonamides
oConcomitant treatment with neuroleptic drugs
oMore than 4 consecutive weeks of freedom from seizure during baseline phase

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study objective is to assess the efficacy and safety of different doses of an add-on antiepileptic treatment with zonisamide in a larger patient population with focal epilepsy;Secondary Objective: Efficacy will be determined using the following parameters: <br>Number of seizures in 28 days intervals, responder rates, number of patients free from seizures during the last 28 days of the study, and clinical global impression of change (CGI-C).<br>Safety will be assessed with the help of the survey of adverse events and the results of physical examinations and clinical laboratory tests.<br>;Primary end point(s): Primary endpoint is the change in the number of epileptic seizures in the time period of 13 to 16 weeks after the beginning of treatment compared to the standardized baseline phase

Secondary Outcome Measures