E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10015037 |
E.1.2 | Term | 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 trial is to evaluate efficacy of BGG492 100mg (administered orally TID) compared to placebo assessed as change in seizure frequency from the 4-week baseline period (Week -4 to -1) to the 100mg double-blind maintenance period (Week 7-10). |
|
E.2.2 | Secondary objectives of the trial |
Secondary Objectives are to evaluate: - responder rate of BGG492 compared to Placebo during the 4-week BGG492 100mg double-blind maintenance period - the efficacy of BGG492 compared to placebo assessed as change in seizure frequency from the 4-week baseline period to the 50mg double-blind maintenance period - responder rate of BGG492 compared to Placebo during the 4-week BGG492 50mg double-blind maintenance period - the efficacy of BGG492 compared to placebo assessed as change in seizure frequency from the 4-week baseline period to the 10-week double-blind treatment evaluation phase - responder rate of BGG492 compared to Placebo during the 10-week double-blind treatment evaluation phase - the proportion of seizure-free patients on BGG492 capsules compared to placebo - PK of BGG492, all doses administered orally TID, in patients with partial onset seizures - plasma levels of concomitant AEDs before and at the end of the treatment ... |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male&female outpatients age 18 to 65 years - weight sup or equal to 50 kg - have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures - must have at least 4 partial seizures during the 4-week baseline period and the 4 weeks immediately preceding the baseline period - have no 28-day seizure-free period during the 8 weeks preceding randomization - must have a positive test result for iGluR3 antibodies in the blood at screening - must have uncontrolled partial seizures despite having been treated with at least two different anti-epileptic drugs within the last 2 years prior to screening - must have received stable treatment with 1 or a max of 2 AED.... |
|
E.4 | Principal exclusion criteria |
1. Any of the following seizure conditions: - presence of only non-motor simple partial seizures - history of psychogenic seizure - abscences, myoclonic seizures - previous history of Lennox-Gastaut syndrome - history of status epilepticus or seizure clusters - only seizures caused by an underlying medical illness during the 52 weeks prior to randomization. 2. Have been treated with Vangabatrin, MAO inhibitors, Barbiturates, intermittent Benzodiazepines, L-dopa formulations, concomitant use of potential inhibitors of OATP transporters .... |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Seizure counts (partial seizures only) during the 28-day baseline period and the Weeks 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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | 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) | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 |
|
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
|
when all randomized patients have met one of the following conditions: - completed the double-blind Treatment Evaluation Phase plus Day 78 assessments and entered the separate extension study on Day 78; - completed the double-blind Treatment Evaluation Phase and the Double-blind Dose-tapering Phase on Day 85; - discontinued double-blind Treatment Evaluation Phase prematurely, and either completed or prematurely discontinued from the 2 week Double-blind Dose-tapering Phase.
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |