Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy

NCT00242606 | Completed Phase 3 DMC

• 1 other identifier: LaLiMo
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Newly diagnosed epilepsy; Initial monotherapy; Levetiracetam; Lamotrigine

Outcome Measures

Primary Outcomes (1)

• Rate of seizure-free patients

  in the first 6 weeks of the trial

Secondary Outcomes (6)

• Rate of seizure-free patients

  during the last 16 weeks

• rate of seizure-free patients

  during the total 26 weeks of the observation period

• time until the first seizure appears

  untin week 26

• time patients take the study medication

  until week 26

• safety

  until end of week 26

Study Arms (2)

1

ACTIVE COMPARATOR

Levetiracetam 2000mg/day

Drug: Levetiracetam

2

ACTIVE COMPARATOR

Lamotrigine

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

titrate to 200mg over 10 weeks and maintained until end of week 26

2

Levetiracetam DRUG

titrate to 2000mg/day over 22 days, maintain until the end of week 26

1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• UCB Pharma GmbH: collaborator

Study Sites (1)

Philipps University Marburg Medical Center, Department of Neurology

Marburg, 35033, Germany

Location

Related Publications (4)

• Brodie MJ, Shorvon SD, Canger R, Halasz P, Johannessen S, Thompson P, Wieser HG, Wolf P. Commission on European Affairs: appropriate standards of epilepsy care across Europe.ILEA. Epilepsia. 1997 Nov;38(11):1245-50. doi: 10.1111/j.1528-1157.1997.tb01224.x. No abstract available.

  PMID: 9579928 BACKGROUND

• Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol Ther. 2000 Feb;85(2):77-85. doi: 10.1016/s0163-7258(99)00052-2.

  PMID: 10722121 BACKGROUND

• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

  PMID: 10660394 BACKGROUND

• Rosenow F, Schade-Brittinger C, Burchardi N, Bauer S, Klein KM, Weber Y, Lerche H, Evers S, Kovac S, Hallmeyer-Elgner S, Winkler G, Springub J, Niedhammer M, Roth E, Eisensehr I, Berrouschot J, Arnold S, Schroder M, Beige A, Oertel WH, Strzelczyk A, Haag A, Reif PS, Hamer HM; LaLiMo Study Group. The LaLiMo Trial: lamotrigine compared with levetiracetam in the initial 26 weeks of monotherapy for focal and generalised epilepsy--an open-label, prospective, randomised controlled multicenter study. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1093-8. doi: 10.1136/jnnp-2011-301999. Epub 2012 May 17.

  PMID: 22595362 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine; Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines

Study Officials

• Felix Rosenow, M.D.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med; PI

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 20, 2005
• Study Start: March 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: January 1, 2009
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

DE (1)