Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00113165

Purpose

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Condition	Intervention	Phase
Epilepsy Epilepsy, Partial	Drug: LAMICTAL extended-release	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase. [ Time Frame: 24 Weeks ]

Secondary Outcome Measures:

Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics [ Time Frame: 24 Weeks ]

Estimated Enrollment:	204
Study Start Date:	October 2004

Intervention Details:

Other Name: LAMICTAL extended-release

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of epilepsy with partial seizures for more than 24 weeks.
Must experience at least 8 partial seizures during an 8-week Baseline Phase.
Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria:

Previous treatment with lamotrigine.
Exhibits any primary generalized seizures.
Receiving treatment with felbamate or currently following the ketogenic diet.
Pregnant, breastfeeding, or planning to become pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113165

Show 82 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Publications:

Erratum: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2009;72;201

Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. Erratum in: Neurology. 2009 Jan 13;72(2):201.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00113165 History of Changes
Other Study ID Numbers:	LAM100034
Study First Received:	June 6, 2005
Last Updated:	March 17, 2011
Health Authority:	India: Indian Council of Medical Research; Brazil: National Health Surveillance Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Instituto de Salud Publica de Chile; South Korea: Korea Food and Drug Administration (KFDA); Germany: Federal Institute for Drugs and Medical Devices; Russia: Ministry of Health and Social Development of the Russian Federation; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Epilepsy
partial seizures
lamotrigine
antiepileptic drugs

LAMICTAL
seizures
anticonvulsants

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lamotrigine

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012