Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy

This study has been completed.
Sponsor:
Collaborator:
UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany
Information provided by (Responsible Party):
Felix Rosenow, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00242606
First received: October 19, 2005
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Lamotrigine
Drug: Levetiracetam
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Rate of seizure-free patients [ Time Frame: in the first 6 weeks of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 409
Study Start Date: March 2005
Study Completion Date: January 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242606

Locations
Germany
Philipps University Marburg Medical Center, Department of Neurology
Marburg, Germany, 35033
Sponsors and Collaborators
Philipps University Marburg Medical Center
UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany
Investigators
Principal Investigator: Felix Rosenow, M.D. Philipps University Marburg Medical Center
  More Information

Publications:
Additional 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     History of Changes
Other Study ID Numbers: LaLiMo
Study First Received: October 19, 2005
Last Updated: May 8, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:
Newly diagnosed epilepsy
Initial monotherapy
Levetiracetam
Lamotrigine

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Lamotrigine
Anticonvulsants
Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 18, 2014