Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
Condition: Focal Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Levetiracetam; Carbamazepine; Lamotrigine
Intervention description: LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.; CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.; LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.
Intervention MeSH terms: Lamotrigine; Carbamazepine; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 361.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: elderly; focal epilepsy; anticonvulsive; treatment; levetiracetam; lamotrigine; carbamazepine

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.
    

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.