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Pediatric Epilepsy Trial in Subjects 1-24 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043875
First received: August 14, 2002
Last updated: September 13, 2016
Last verified: September 2016
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: May 2000
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 24 Months   (Child)
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
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: NCT00043875

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
Los Angeles, California, United States, 90095
GSK Investigational Site
Stanford, California, United States, 94305-5235
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80218
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32207
GSK Investigational Site
Miami, Florida, United States, 33155-3009
GSK Investigational Site
Orlando, Florida, United States, 32835
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33607-6350
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55102-2383
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64108
United States, New Jersey
GSK Investigational Site
Cherry Hill, New Jersey, United States, 8034
United States, New York
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Columbus, Ohio, United States, 43205
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97227
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2583
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
GSK Investigational Site
Norfolk, Virginia, United States, 23510
GSK Investigational Site
Richmond, Virginia, United States, 23298
Australia, Queensland
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
GSK Investigational Site
Parkville, Melbourne, Victoria, Australia, 3050
GSK Investigational Site
West Heidleberg, Melbourne, Victoria, Australia
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
France
GSK Investigational Site
Reims Cedex, France, 51092
Hungary
GSK Investigational Site
Budapest, Hungary, 1094
GSK Investigational Site
Debrecen, Hungary, 4012
GSK Investigational Site
Miskolc, Hungary, 3526
GSK Investigational Site
Szeged, Hungary, 6720
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Mantova, Lombardia, Italy, 46100
GSK Investigational Site
Milano, Lombardia, Italy, 20133
GSK Investigational Site
Messina, Sicilia, Italy, 98125
GSK Investigational Site
Padova, Veneto, Italy, 35128
Latvia
GSK Investigational Site
Riga, Latvia, LV 1004
Lebanon
GSK Investigational Site
Beirut, Lebanon, 11072020
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-50009
Netherlands
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Utrecht, Netherlands, 3584 EA
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-075
GSK Investigational Site
Lisboa, Portugal, 1150
GSK Investigational Site
Porto, Portugal, 4099-001
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bratislava, Slovakia, 833 40
GSK Investigational Site
Presov, Slovakia, 080 01
Spain
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
Turkey
GSK Investigational Site
Ankara, Turkey
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LAM20006
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043875     History of Changes
Other Study ID Numbers: LAM20006 
Study First Received: August 14, 2002
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
partial seizures
pediatric
epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Anticonvulsants
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

ClinicalTrials.gov processed this record on December 02, 2016