Status:
COMPLETED
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
UCB Pharma GmbH
Conditions:
Focal Epilepsy
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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. A...
Detailed Description
Indication: Focal Epilepsy Objectives: To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00438451
Start Date
January 1 2007
End Date
August 1 2011
Last Update
February 28 2013
Active Locations (1)
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1
Department of Neurology, University of Mainz Medical Centre
Mainz, Germany, 55101