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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: January 16, 2017
Last verified: January 2017
  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
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:
  • Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation [ Time Frame: 43 Months ]
  • Change from baseline in vital signs -heart rate (HR) [ Time Frame: Up to 43 Months ]
  • Change from baseline in vital signs - weight (WT) [ Time Frame: Up to 43 months ]
  • Change from baseline in vital signs - height (HT) [ Time Frame: Up to 43 months ]
  • Change from baseline in vital signs - head circumference (HC) [ Time Frame: Up to 43 months ]
  • Change from baseline in clinical chemistry parameters including Albumin and Total protein [ Time Frame: Up to month 43 ]
  • Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST) [ Time Frame: Up to 43 moths ]
  • Change from baseline in clinical chemistry parameters including total bilirubin and creatinine [ Time Frame: Up to 43 months ]
  • Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea [ Time Frame: Up to 43 months ]
  • Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC) [ Time Frame: Up to 43 moths ]
  • Change from baseline in Hemoglobin (Hb) [ Time Frame: Up to 43 months ]
  • Change from baseline in Mean corpuscular hemoglobin (MCH) [ Time Frame: Up to 43 months ]
  • Change from baseline in Mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: Up to 43 months ]
  • Change from baseline in mean corpuscular volume (MCv) [ Time Frame: Up to 43 months ]
  • Change from baseline in red blood cells (RBC) [ Time Frame: Up to 43 months ]
  • Number of participants with treatment emergent neurological abnormalities [ Time Frame: Up to 43 months ]
  • Number of participants with treatment emergent clinically significant ECG abnormalities [ Time Frame: Up to 43 months ]
  • Number of participants with potentially clinically significant change in hematology parameters [ Time Frame: Up to 43 months ]
  • Number of participants with potentially clinically significant change in clinical chemistry parameters [ Time Frame: Up to 43 months ]
  • Number of participants with potentially clinically significant change in vital signs [ Time Frame: Up to 43 months ]

Secondary Outcome Measures:
  • Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase [ Time Frame: Up to 48 Weeks ]
  • Investigator's assessment of the participant's overall clinical status [ Time Frame: Up to 43 months ]
  • Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants [ Time Frame: Week 6 ]

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)
  Eligibility

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

  Show 70 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LAM20007
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LAM20007
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LAM20007
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: LAM20007
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LAM20007
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: LAM20007
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: LAM20007
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044278     History of Changes
Other Study ID Numbers: LAM20007
Study First Received: August 23, 2002
Last Updated: January 16, 2017
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:
epilepsy
pediatric
partial seizures

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 March 29, 2017