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Pediatric Epilepsy Study in Subjects 1-24 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044278
First received: August 23, 2002
Last updated: April 11, 2013
Last verified: September 2012
  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 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: 225
Study Start Date: September 2000
Intervention Details:
    Drug: lamotrigine
    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
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 ClinicalTrials.gov identifier: NCT00044278

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044278     History of Changes
Other Study ID Numbers: LAM20007
Study First Received: August 23, 2002
Last Updated: April 11, 2013
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
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014