Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johannes Gutenberg University Mainz
• Collaborator: UCB Pharma GmbH
• Treatments: Anticonvulsants; Carbamazepine; Etiracetam; Lamotrigine; Levetiracetam; Piracetam

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.