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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00044278

Purpose

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Condition	Intervention	Phase
Epilepsy	Drug: lamotrigine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

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 long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests. [ Time Frame: 43 Months ]

Secondary Outcome Measures:

Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators global evaluation of subjects status; standard pharmacokinetics. [ Time Frame: 43 Months ]

Enrollment:	225
Study Start Date:	September 2000

Intervention Details:

Other Name: lamotrigine

Eligibility

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

Criteria

Inclusion criteria:

Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
A confident diagnosis of epilepsy.
4 or more partial seizures per month.
current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

Has seizures not related to epilepsy.
Has a surgically implanted and functioning vagal nerve stimulator.
Has previously been treated with lamotrigine.
Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
Use of experimental medication within 30 days of enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044278

Show 70 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00044278 History of Changes
Other Study ID Numbers:	LAM20007
Study First Received:	August 23, 2002
Last Updated:	May 26, 2011
Health Authority:	Lithuania: State Medicine Control Agency - Ministry of Health; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

partial seizures
epilepsy
pediatric

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 09, 2012