E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory partial-onset seizures |
|
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 |
|
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 detect a dose-response of BGG492 (administered orally TID) as measured by change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 4-week double-blind maintenance period (Weeks 7 to 10). |
|
E.2.2 | Secondary objectives of the trial |
The key secondary objective is to evaluate the efficacy of BGG492 (100mg, 150 mg) administered orally TID compared to placebo assessed as change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 4-week double-blind maintenance period (Weeks 7 to 10). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria: - male or female - weight sup or equal to 50kg - Have a diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy’s Classification of Epileptic Seizures (ILAE, 1981); Appendix 5; The diagnosis should have been established by clinical history and abnormal electroencephalogram (EEG) that is consistent with localization-related epilepsy (For Cohort 1 an abnormal EEG must be dated > 2 years prior screening for inclusion. For Cohort 2, an abnormal EEG is acceptable at any time prior to screening provided that clinical history documents localization-related epilepsy along with AED treatment for > 2 years prior to screening). - have uncontrolled partial seizures - have at least 4 partial seizures - have no 28-day seizure-free period during the 8 weeks preceding randomization - Cohort 1 patients must be receiving stable treatment (see inclusion criteria 8.1-8.4 and 9) with 1 or a maximum of 2 AEDs ; whereas, Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs
please refer to protocol for the full list |
|
E.4 | Principal exclusion criteria |
Key exclusion criteria:Any of the following seizure conditions: - Presence of only non-motor simple partial seizures - History of psychogenic seizures within 52 weeks prior to screening; - Absences and/or myoclonic seizures e.g. in the context of primarily generalized epilepsy - Previous history of Lennox-Gastaut syndrome - Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgement of the investigator occuring within 52 weeks prior to randomization.
please refert to protocol for the full list |
|
E.5 End points |
E.5.1 | Primary end point(s) |
primary efficacy assessment: seizure counts (partial seizures only)during the 28-day baseline period and the week 7-10 maintenance period in comparison to placebo.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |