Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00242606 |
|
Recruitment Status :
Completed
First Posted : October 20, 2005
Last Update Posted : May 9, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study |
| Study Start Date : | March 2005 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: 1
Levetiracetam 2000mg/day
|
Drug: Levetiracetam
titrate to 2000mg/day over 22 days, maintain until the end of week 26 |
|
Active Comparator: 2
Lamotrigine
|
Drug: Lamotrigine
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
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
| Germany | |
| Philipps University Marburg Medical Center, Department of Neurology | |
| Marburg, Germany, 35033 | |
| Principal Investigator: | Felix Rosenow, M.D. | Philipps University Marburg Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Felix Rosenow, Prof. Dr. med; PI, Philipps University Marburg Medical Center |
| ClinicalTrials.gov Identifier: | NCT00242606 |
| Other Study ID Numbers: |
LaLiMo |
| First Posted: | October 20, 2005 Key Record Dates |
| Last Update Posted: | May 9, 2012 |
| Last Verified: | May 2012 |
|
Newly diagnosed epilepsy Initial monotherapy Levetiracetam Lamotrigine |
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Lamotrigine Levetiracetam Anticonvulsants Nootropic Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |