E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory partial-onset seizures |
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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 | 10065336 |
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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 evaluate the efficacy of BGG492 100 mg (administered orally TID) compared to placebo assessed as a change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 100 mg maintenance double-blind period (Week 7 ? Week 10). The evaluation of an additional arm is planned depending on the availability of additional data. |
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E.2.2 | Secondary objectives of the trial |
The key secondary objective is to evaluate the responder rate (responder defined as patients with a 50% or greater reduction in seizure frequency from baseline) of BGG492 (administered orally TID) compared to the placebo during the 4-week (Week 7 ? Week 10) 100 mg double-blind maintenance period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria: ? Male and female outpatients age 18 to 65 years (inclusive) ? Weight of ≥ 50 kg (110 lb) ? 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 ? Have uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs within the last 2 years prior to screening (given concurrently or sequentially) ? Have at least 4 partial seizures (defined as simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization or a combination of these types for this inclusion criterion) during the 4-week baseline period and the 4 weeks immediately preceding the baseline period (retrospective and/or prospective data) ? Have no 28-day seizure-free period during the 8 weeks preceding randomization. ? Must be receiving stable treatment with 1 or a maximum of 2 AEDs |
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E.4 | Principal exclusion criteria |
Key exclusion criteria: ? Any of the following seizure conditions: Presence of only non-motor simple partial seizures Psychogenic seizures Absences and/or myoclonic seizures e.g. in the context of primary generalized epilepsy; Previous history of Lennox-Gastaut syndrome Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgment of the investigator occurring within 52 weeks prior to randomization |
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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. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | 5 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |