Pediatric Epilepsy Trial in Subjects 1-24 Months - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00043875

Purpose

This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

Condition	Intervention	Phase
Epilepsy	Drug: lamotrigine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Add-on Clinical Trial of the Safety, Pharmacokinetics and Efficacy of LAMICTAL in Pediatric Age Subjects (1-24 Months)

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 add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. [ Time Frame: 36 Months ]

Secondary Outcome Measures:

Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events [ Time Frame: 36 Months ]

Enrollment:	250
Study Start Date:	May 2000

Eligibility

Ages Eligible for Study:	1 Month to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Have a confident diagnosis of epilepsy
Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
Have no underlying chronic metabolism problems
Have normal lab results
Have a normal electrocardiogram (ECG)

EXCLUSION CRITERIA:

Have a diagnosis of severe, progressive myoclonus.
Have seizures not related to epilepsy.
Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
Have progressive or unstable condition of the nervous system.
Used experimental medication within 30 of enrollment into the study.
Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
Current use of the medication felbamate.
Current use of adrenocorticotrophic hormone (ACTH).
Following a ketogenic diet.
Receiving vagal nerve stimulation (VNS).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043875

Show 63 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:	LAM20006
Study First Received:	August 14, 2002
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00043875 History of Changes
Health Authority:	United States: Food and Drug Administration; Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by GlaxoSmithKline:

epilepsy
partial seizures
pediatric

Additional relevant MeSH terms:

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

Membrane Transport Modulators
Epilepsy
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010