Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study|
- Rate of seizure-free patients [ Time Frame: in the first 6 weeks of the trial ] [ Designated as safety issue: No ]
- Rate of seizure-free patients [ Time Frame: during the last 16 weeks ] [ Designated as safety issue: No ]
- rate of seizure-free patients [ Time Frame: during the total 26 weeks of the observation period ] [ Designated as safety issue: No ]
- time until the first seizure appears [ Time Frame: untin week 26 ] [ Designated as safety issue: No ]
- time patients take the study medication [ Time Frame: until week 26 ] [ Designated as safety issue: No ]
- safety [ Time Frame: until end of week 26 ] [ Designated as safety issue: Yes ]
- quality of life during treatment [ Time Frame: until week 26 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
titrate to 2000mg/day over 22 days, maintain until the end of week 26
Active Comparator: 2
titrate to 200mg over 10 weeks and maintained until end of week 26
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 [Kwan & Brodie 2000]. Therefore new drugs and an expansion of permission for drugs with limited approval, respectively, are needed.
Levetiracetam is a new potent antiepileptic drug with nearly ideal pharmacokinetic properties and few side effects [Patsalos 2000], but it is approved in Germany only for add-on therapy for patients > 15 years of age with focal epilepsy.
Due to its few cognitive side effects and its efficacy, Lamotrigine is becoming standard therapy for focal and generalized epilepsy for patients from >11 years of age. Its disadvantage is the possibility of severe allergic reactions which limits the speed of dose increment.
Comparisons: Patients with newly diagnosed epilepsy are treated with either Lamotrigine or Levetiracetam. Rate of seizure-free patients in the first 6 weeks of the trial (main outcome criterion) as well as rate of seizure-free patients during the last 16 weeks and the total 26 weeks of the observation period, time until the first seizure appears, time patients take the study medication, safety and quality of life during treatment are compared.
|Philipps University Marburg Medical Center, Department of Neurology|
|Marburg, Germany, 35033|
|Principal Investigator:||Felix Rosenow, M.D.||Philipps University Marburg Medical Center|