Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242606
Status:
COMPLETED
Last Update Posted:
2012-05-09
First Post:
2005-10-19
Brief Title:
Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy An Open Prospective Multicenter Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 - 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None