Newly diagnosed focal epilepsy Nervous System Diseases Focal epilepsy
Conditions
Interventions
The study will consist of a six week titration phase and a 52 week maintenance phase. Patients who successfully complete the trial (final visit [V6]) will be unblinded and offered either to continue o
Sponsors
University of Mainz Medical Faculty (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 60 years or above 2. New onset focal epilepsy (either at least one epileptic seizure in the last six months and focal epileptiform discharges on electroencephalogram (EEG) or a relevant lesion on computed tomography (CT)/magnetic resonance imaging (MRI) or at least two epileptic seizures, one of which occurred in the last six months prior inclusion) 3. No previous anti-epileptic drug (AED) treatment, except for a period not longer than four weeks prior to inclusion (V0) 4. 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 5. Written informed consent before enrolment in the trial
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following criteria will not be included in the trial: 1. Acute symptomatic epileptic seizures occurring acutely within a two 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) 2. Dementia (as defined by history) 3. Renal insufficiency as defined by glomerular filtration rate (GFR) less than 50 ml/min 4. Increased liver enzymes (glutamic-oxaloacetic transaminase [GOT], glutamic-pyruvic transaminase [GPT], gamma-glutamyl-transferase [gGT]) or increased bilirubin more than or equal to twofold the upper limit of normal (ULN) 5. Pre-treatment with valproic acid within the four weeks prior inclusion (V0) 6. 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 7. Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the 58-week retention rate measured by the number of drop outs due to adverse events or seizures from day one of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: 1. Proportion of patients remaining seizure-free at week 30 (V4) 2. Proportion of patients remaining seizure free at week 58 (V6) 3. The time (in days) to first break-through seizure (from day one of treatment) 4. The absolute seizure frequency during the maintenance (over 52 weeks) phase 5. Proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase 6. The frequency of adverse events (from day one of treatment) 7. Quality Of Life In Epilepsy (QOLIE-31) survey results at V6 8. Portland Neurotoxicity scale at V6 9. Results of cognitive testing (EpiTrack© by UCB) | — |
Countries
Austria, Germany, Switzerland
Outcome results
None listed