Partial epileptic seizures with or without secondary generalisation MedDRA version: 7.1 Level: PT Classification code 10040703
Conditions
Interventions
Product Name: Zonisamide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Zonisamide (INN.L25.E)
CAS Number: 0068291-97-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Eisai GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Adult aged between 18 years and 74 years o Focal epileptic seizures with or without secondary generalization o Present 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. o At 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
Exclusion criteria: o Epileptic state during the past year o Non-epileptic fits o Generalized epilepsy o Concomitant progressive CNS disease including progressive myoclonus epilepsy o Concomitant treatment with vigabatrine and/or topiramate o Hepatic and/or renal insufficiency (creatinine > 2 mg% or GPT > 2 times ULN) o Body 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 o Active psychosis o Suicide attempt during the past 3 years o Pre-treatment with zonisamide o Known hypersensitivity to sulfonamides o Concomitant treatment with neuroleptic drugs o More than 4 consecutive weeks of freedom from seizure during baseline phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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). Safety will be assessed with the help of the survey of adverse events and the results of physical examinations and clinical laboratory tests. ;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 | — |
Countries
Germany
Outcome results
None listed