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.1.3 | 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. seizures as required by regulatory guidelines. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the 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 study CBGG492A2207 to the Open-label Extension Maintenance Phase; • To evaluate the maintenance of efficacy over time as assessed by the change in responder rate and numbers of patients becoming seizure free from the Baseline Period in study CBGG492A2207 to the Open-label Extension Maintenance Phase; • To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic effect and all other reasons .
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female outpatients age 18 to 66 years (inclusive) with weight of ≥ 45 Kg (99 lb); • Completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues; • Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected; • Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed; • Provided written informed consent before any extension assessment is performed. |
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E.4 | Principal exclusion criteria |
• History of status epilepticus or seizure clusters occurring during Study CBGG492A2207 or in the period between the end of study CBGG492A2207 and the start of study CBGG492A2212 for patients experiencing a treatment gap. • Patients who have been treated with: • Felbamate, unless treatment has been continuous for ≥ 2 years; • Vigabatrin during 26 weeks prior to the first dose of open-label medication in the extension study; • Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of openlabel medication in the extension study; • L-Dopa formulations; • Used concomitant medication that are potential inhibitors of OATP transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study. • No physical examination changes suggestive of progressive neurological changes (e.g. Alzheimer’s disease, Parkinson’s Disease, Multiple Sclerosis) during Study CBGG492A2207; • History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides); • Pregnant or lactating females. |
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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 |