Clinical trial NCT00242606 (phase 3, status: completed)
Conditions: epilepsy
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: lamotrigine, levetiracetam
SMILES: NC1=NC(N)=C(N=N1)C1=C(Cl)C(Cl)=CC=C1, CC(C)CC1=CC=C(C=C1)C(C)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 12 years

          -  Body weight ≥ 30kg (patients 12-15 years of age) and ≥ 40kg (patients over 16 years of
             age), respectively

          -  Either one epileptic seizure with high risk of relapse (partial seizure semiology, MRI
             lesion or pathological focal EEG findings) or a newly diagnosed epilepsy (≥ 2
             unprovoked seizures) with at least 1 seizure within the past 3 months before begin of
             trial participance

          -  Treatment with no or a maximum of one anticonvulsant drug at the time of inclusion

          -  Fertile women of ≥ 16 years of age must use at least one of the following
             contraceptives for at least one month prior to initiation of trial participance: Oral
             contraceptive, contraceptive diaphragm, intrauterine contraceptive device (coil), tube
             ligation. For girls between 12 and 15 years of age a written confirmation of sexual
             abstinence, given by a person having the care and custody of the child, is sufficient.

          -  Informed consent by the proband in written form after being informed about character,
             relevance and consequences of the clinical trial, and additional informed consent
             given by a person having the care and custody of the child for patients between 12 and
             17 years of age, respectively.

        Exclusion Criteria:

          -  Patients with non-epileptic seizures or acute symptomatic seizures whose cause can be
             corrected

          -  Patients who suffer from absence seizures or simple partial seizures without motor
             signs (aura) only

          -  Patients who had a chronic focal epilepsy or an epileptic state in their medical
             history

          -  Patients with progressive neurological, degenerative or malignant diseases which are
             clinically relevant from the investigator's point of view (e.g. cardiovascular or
             endocrinic diseases)

          -  Patients who have been treated with Levetiracetam or Lamotrigine before

          -  Patients with known manifest renal insufficiency (creatinine clearance < 80 mL/min)

          -  Patients with known hypersensitivity to Levetiracetam, Lamotrigine or another
             component of the trial drugs

          -  Patients who are attended by a legal guardian

          -  Patients suffering from a psychiatric disease or affective disorders (within the past
             6 months), which had to be treated with electric convulsive therapy, tranquilizing
             agents, monoamine oxidase inhibitors or CNS-active sympathomimetics (e.g.
             methylphenidate)

          -  Patients who were suffering from alcohol- or drug-addiction within the past 12 months

          -  Pregnant or breast-feeding women

          -  Patients who participated in another clinical trial within the past 30 days