Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 6:18 PM
Study NCT ID:
NCT00242606
Status:
COMPLETED
Last Update Posted:
2012-05-09
First Post:
2005-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
Sponsor:
Philipps University Marburg
Organization:
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 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.
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:
True
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?: