E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory partial 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 | 10040703 |
E.1.2 | Term | Simple partial seizures |
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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 the study is to assess the efficacy of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial seizures. The primary analysis variables for the assessment of efficacy will be: 1. the responder rate, defined as the proportion of patients with at least a 50% decrease in the standardised seizure frequency 2. the relative reduction in the standardised seizure frequency |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: To assess the safety and tolerability of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial seizures To assess the proportion of seizure-free patients and of patients with more than 75% reduction in seizure frequency To assess the frequency of patients with exacerbations To assess the duration of seizures and severity of seizures (using the Hague seizure severity scale) To assess the potential for rebound effects and withdrawal phenomena To assess the potential for interactions between Eslicarbazepine Acetate and concomitant AED medication To assess the seizure frequency by seizure type To assess the maintenance of the therapeutic effect of Eslicarbazepine Acetate during long-term treatment in Part II of the study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria Children aged 2 to 16 years Diagnosis of epilepsy for at least 6 months prior to enrolment At least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs At least 4 partial-onset seizures during each 4 week interval of the 8 week baseline period Current treatment with 1 or 2 AEDs (any AED except oxcarbazepine) Stable dose regimen of AEDs during the 8 week baseline period Cooperation and willingness to complete all aspects of the study, including hospitalisation if required Written informed consent to participate in the study in accordance with local legislation |
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E.4 | Principal exclusion criteria |
Exclusion criteria Primarily generalised seizures Baseline seizure frequency substantially different from usual seizure frequency Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion) History of status epilepticus within the 3 months prior to enrolment Seizures of non-epileptic origin (e.g. metabolic or neoplastic, or related to active infection) Lennox-Gastaut syndrome West syndrome Major psychiatric disorders Previous treatment in any study with Eslicarbazepine Acetate |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to assess the efficacy of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial seizures. The primary analysis variables for the assessment of efficacy will be: 1. the responder rate, defined as the proportion of patients with at least a 50% decrease in the standardised seizure frequency 2. the relative reduction in the standardised seizure frequency |
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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 | Yes |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.6 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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |