E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy Partial onset seizures |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065336 |
E.1.2 | Term | Partial 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 |
Primary Objective is to evaluate the long-term safety, tolerability and efficacy data for BGG492 at oral doses of 20mg, 50mg, 100mg TID administered as adjunctive therapy in adult patients with partial onset seizures. The total daily dose of BGG492 administered during the study will be 60mg, 150mg or 300mg depending on the patient tolerability. |
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E.2.2 | Secondary objectives of the trial |
- evaluate maintenance of efficacy over time as assessed by the change in partial seizure frequency from the original Baseline Period (28 days) in the double-blind studies BGG492A2207 and BGG492A2211 to the Open-label Extension Maintenance Phase - evaluate maintenance of efficacy over time as assessed by the change in responder rate and numbers of patients becoming seizure free from the Baseline Period (28 days) in the double-blind studies BGG492A2207 and BGG492A2211 to the Open-label Extension Maintenance Phase - evaluate long-term efficacy - evaluate PK, plasma levels of concomitant AEDs, number of seizures during BGG tapering off, QoL and the total HADS score.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Have completed 10 week double-blind treatment evaluation Phase plus one week of dose-tapering in study 2207 or 2211, have cooperated in study procedures and have been perceived by investigator as deriving benefit from taking the study medication without experiencing tolerability issues. - patients who wish to continue BGG492 treatment - male and female outpatients age 18 to 66 Years (inclusive) - weight sup or equal to 45kg - are currently treated with a stable dose of 1 or max 2 licensed AEDs - are reliable - have provided written informed consent |
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E.4 | Principal exclusion criteria |
- history of status epilepticus or seizure clusters occuring during study 2207 or 2211 - patients with a planned brain surgery in the next 6 months - no physical examination changes suggestive of progressive neurological changes (AD, PD, MS) - patients who received prohibited medication or used benzodiazepines intermittently during the double-blind studies - history of hypersensitivity to study drug or to drugs of similar chemical classes - etc.... |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seizure frequency and seizure types |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | Yes |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |