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: August 19, 2015
Last verified: August 2015

August 14, 2002
August 19, 2015
May 2000
November 2003   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00043875 on ClinicalTrials.gov Archive Site
  • The difference in the time to escape patterns between LAMICTAL and placebo [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a reduction in monthly partial seizure frequency from baseline between 40%-80% at the end of the Open-Label Phase [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Percent change from baseline in seizure frequency at the end of the Open-Label Phase by seizure type [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The investigators' global evaluation of the subjects' status at the end of the Open-Label and Double-Blind Phases [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - Maximum Plasma Concentration (Cmax) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]
  • The incidence of adverse events over the course of the study [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The change from baseline in clinical laboratory and vital sign values [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - Area Under the Curve (AUC) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - CL/F (Oral clearance) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]
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Pediatric Epilepsy Trial in Subjects 1-24 Months
A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Epilepsy
Drug: lamotrigine
Other Name: lamotrigine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
November 2003
November 2003   (final data collection date for primary outcome measure)

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).
Both
1 Month to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Estonia,   Latvia,   Lebanon,   Netherlands,   Spain,   Turkey
France,   Hungary,   Italy,   Lithuania,   Portugal,   Slovakia,   Egypt
 
NCT00043875
LAM20006
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP