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: April 11, 2013
Last verified: May 2011

August 14, 2002
April 11, 2013
May 2000
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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 ]
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Complete list of historical versions of study NCT00043875 on ClinicalTrials.gov Archive Site
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 ]
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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
Primary Purpose: Treatment
Epilepsy
Drug: lamotrigine
Other Name: lamotrigine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
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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
 
NCT00043875
LAM20006
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2011

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