Patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven?t obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months. MedDRA version: 9.1 Level: LLT Classification code 10065337 Term: Focal epilepsy
Conditions
Interventions
Trade Name: ZONEGRAN
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Zonisamide
Concentration type: equal
Sponsors
Eisai s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age ≥ 18 years; Patients with non progressive localization-related epilepsy; Patients who are able and willing to give written Informed Consent; Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide; Patients in treatment with zonisamide for at least three months Patients with the laboratory test reports requested by the protocol (see par. 8.3)available and performed not more than three months before the first screening visit Inclusion criteria ? baseline visit: Responder Patients (50% or greater seizure reduction) as assessed after an at least three-month maintenance period with zonisamide*. * = seizure frequency before starting zonisamide must be documented checking case histories. 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: patients contraindicated for zonisamide use (see SmPC); Patients with renal or hepatic impairment as assessed with medical history review; Pregnant or lactating women; Women of childbearing age who are not willing to use any contraceptive method with established efficacy. Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation; Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency; Patients who have been on an investigational drug within 30 days prior to the initiation of the present study; Patients with a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the safety and efficacy of the triple therapy vs the double therapy.;Secondary Objective: Non previsti;Primary end point(s): Primary: cumulative probability of withdrawing from the assigned treatment arm. | — |
Countries
Italy
Outcome results
None listed