E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with localization-related epilepsy, who have added a second drug to the monotherapy, havent obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065337 |
E.1.2 | Term | Focal epilepsy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: cumulative probability of withdrawing from the assigned treatment arm. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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conclusione della sperimentazione NON DEFINITA nel protocollo |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |