Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
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|ClinicalTrials.gov Identifier: NCT00242606|
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : May 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lamotrigine Drug: Levetiracetam||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||409 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study|
|Study Start Date :||March 2005|
|Primary Completion Date :||June 2008|
|Study Completion Date :||January 2009|
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
- Rate of seizure-free patients [ Time Frame: in the first 6 weeks of the trial ]
- Rate of seizure-free patients [ Time Frame: during the last 16 weeks ]
- rate of seizure-free patients [ Time Frame: during the total 26 weeks of the observation period ]
- time until the first seizure appears [ Time Frame: untin week 26 ]
- time patients take the study medication [ Time Frame: until week 26 ]
- safety [ Time Frame: until end of week 26 ]
- quality of life during treatment [ Time Frame: until week 26 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242606
|Philipps University Marburg Medical Center, Department of Neurology|
|Marburg, Germany, 35033|
|Principal Investigator:||Felix Rosenow, M.D.||Philipps University Marburg Medical Center|