E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with newly diagnosed focal epilepsy aged 60 years or older with at least 1 epileptic seizure and abnormalities on imaging or EEG or with two epileptic seizures within the last 6 month. Patients with acute (< 2 weeks) symptomatic epileptic seizures due to acute brain abnormalities (i.e. haemorrhage or cerebral infarct) or contraindications against any of the drugs in trial will be excluded. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015037 |
E.1.2 | Term | Epilepsy |
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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 |
To evaluate the tolerability and efficacy of levetiracteam (LEV) in newly diagnosed elderly patients with focal epilepsy compared to lamotrigine (LTG) or carbamazepine slow release (CBZ). The primary endpoint will be the proportion of patients who continue to take the study medication (retention rate) over the period of 58 weeks (from day 1 of titration).
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy endpoints will include: • Proportion of patients remaining seizure-free at week 30 (V4). • Proportion of patients remaining seizure-free at week 58 (V6). • The time (in days) to first break-through seizure (from day 1 of treatment). • The absolute seizure frequency during the maintenance (over 52 weeks) phase. • Proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase. • The frequency of adverse events (from day 1 of treatment). • QOLIE-31 at V6 (see appendix of protocoll). • Portland Neurotoxicity scale at V6 (see appendix of protocoll). • Results of cognitive testing (EpiTrack© by UCB, see appendix of protocoll). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects meeting all of the following criteria will be considered for admission to the trial:
- Age 60 yrs or above. - New onset focal epilepsy (adjusted to the definition of the International League Against Epilepsy (ILAE) published in Fisher RS et al. 2005, Epilepsia 46(4):470-72) i.e. either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CT/MRI or at least 2 epileptic seizures, one of which occurring in the last 6 months prior inclusion. - No previous AED treatment, except for a period not longer than 4 weeks prior to inclusion (V0). - Ability of subject to understand verbal and written instructions, to comply with all study requirements, and to comprehend character and individual consequences of the clinical trial. - Written informed consent before enrolment in the trial. |
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following criteria will not be included in the trial: - Acute symptomatic epileptic seizures occurring acutely within a 2 week period after the onset of an acute illness such as cerebral haemorrhage, cerebral infarct, rapid progressive malignancy or other acute brain abnormalities (i.e. encephalitis, hypoxic brain damage, trauma, metabolic derangement, following brain surgery). - Dementia (as defined by history) - Renal insufficiency as defined by GFR < 50 mL/min. - Increased liver enzymes (GOT, GPT, gGT) or increased bilirubin ≥ 2-fold the upper limit of normal (ULN). - Pre-treatment with valproic acid within the four weeks prior inclusion (V0). - Contraindication against or history of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products. - Participation in other clinical trials and observation period of competing trials within the last 2 months, respectively. - History of drug or alcohol abuse within the last 2 years. - Medical condition which interferes with the participation in the trial according to the opinion of the investigator. - Patients with life expectancy < 1 year due to malignant disease. - Psychiatric morbidity requiring legal guardianship. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be: • Proportion of patients who continue to take the study medication (retention rate) over the period of 58 weeks (from day 1 of titration).
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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 | 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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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 | 40 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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
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see Section 5.5 und 7.1 of the protocol |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |