E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
About 40% of the patients suffering from epilepsy are not satisfactorily controlled and 25% suffer from significant adverse events. This lack of seizure control means that combination therapy is often recommended, but a sizeable proportion of patients continue to have regular seizures. Therefore, there is still a need for new, effective AEDs, particularly those that can be used safely as adjuncts to standard therapy. |
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MedDRA Classification |
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 |
Evaluating efficacy of BIA 2-093 once daily at doses of 400, 800 and 1200 mg compared with placebo ad adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period |
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E.2.2 | Secondary objectives of the trial |
(1) To evaluate the safety and tolerability of BIA 2-093 at once-daily doses of 400 mg, 800 mg and 1200 mg in comparison to placebo, over a 12-week maintenance period preceded by a 2-week titration period and followed by a 4-week tapering-off period. (2) To evaluate the safety and tolerability of BIA 2-093 at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. (3) To assess the maintenance of therapeutic effects of BIA 2-093 over a 12-week maintenance period preceded by a 2-week titration period and followed by a 4-week tapering-off period and over a 1-year open-label period. (4) To assess the drug-drug pharmacokinetic interactions between BIA 2-093 and concomitant anti-epileptic drugs over the double-blind and open-label parts of the study. (5) To assess the health-related quality-of-life and depressive symptoms over the double-blind and open-label parts of the study |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
documented diagnosis of simple or complex partial seizures with or withou secondary generalisation since at least 12 months, at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs in a stable dose regimen during at least 2 months prior to screening |
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E.4 | Principal exclusion criteria |
only simple partial seizures with no motor symptomatology, primarily generalised epilepsy, seizures of psychogenic origin, currently on or with exposure to felbamate or oxcarbazepine more within on month of screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seizure frequency over the 12-week maintenance period. Seizure frequency will be standardised to a “frequency per 4 weeks” basis |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
part I: double blind; part II: open |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 |