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Pediatric Epilepsy Study in Subjects 1-24 Months

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 23, 2002
Last updated: April 14, 2015
Last verified: April 2015
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
Drug: lamotrigine
Phase 2

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:

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: 197
Study Start Date: September 2000
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044278

GSK Investigational Site
Beirut, Lebanon, 11072020
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Coimbra, Portugal, 3000-075
GSK Investigational Site
Lisboa, Portugal, 1150
GSK Investigational Site
Porto, Portugal, 4099-001
GSK Investigational Site
Ankara, Turkey
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00044278     History of Changes
Other Study ID Numbers: LAM20007 
Study First Received: August 23, 2002
Last Updated: April 14, 2015
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
partial seizures

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on September 30, 2016