EUCTR2005-000260-57-DE
Active, not recruiting
Not Applicable
Randomized trial to assess efficacy and safety of an add-on treatment with zonisamide in adults with focal epileptic seizures with or without secondary generalization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Partial epileptic seizures with or without secondary generalisation
- Sponsor
- Eisai GmbH
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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