Status:
COMPLETED
Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
Lead Sponsor:
Philipps University Marburg
Collaborating Sponsors:
UCB Pharma GmbH
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy, safety and tolerance of the drugs Lamotrigine and Levetiracetam in the initial monotherapy of patients with newly diagnosed epilepsy.
Detailed Description
Epilepsy is the second most frequent neurologic disease (prevalence 0.5 % - 1 % \[Brodie et al. 1997\]). About 30 % of epilepsy patients (including many children) suffer from intractable seizures \[Kw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00242606
Start Date
March 1 2005
End Date
January 1 2009
Last Update
May 9 2012
Active Locations (1)
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1
Philipps University Marburg Medical Center, Department of Neurology
Marburg, Germany, 35033