Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00438451
Eligibility Criteria:
Inclusion Criteria:
* Age 60 yrs or above.
* New onset focal epilepsy 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00438451
Study Brief:
Protocol Section:
NCT00438451