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

This study has been completed.

First Received: June 6, 2005 Last Updated: August 27, 2009 History of Changes

Sponsored by:	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	Drug: LAMICTAL extended-release	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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: 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

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LAM100034
Study First Received:	June 6, 2005
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00113165 History of Changes
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation; Germany: Federal Institute for Drugs and Medical Devices; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; South Korea: Korea Food and Drug Administration (KFDA); India: Indian Council of Medical Research

Keywords provided by GlaxoSmithKline:

Epilepsy
partial seizures
seizures
lamotrigine

anticonvulsants
antiepileptic drugs
LAMICTAL

Study placed in the following topic categories:

Calcium, Dietary
Signs and Symptoms
Epilepsy
Seizures
Lamotrigine
Calcium Channel Blockers

Neurologic Manifestations
Central Nervous System Diseases
Cardiovascular Agents
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Seizures
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions

Membrane Transport Modulators
Signs and Symptoms
Epilepsy
Therapeutic Uses
Lamotrigine
Neurologic Manifestations
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009