Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 ]

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 ]

Enrollment: 250
Study Start Date: May 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:

  • 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

  Show 32 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043875     History of Changes
Other Study ID Numbers: LAM20006
Study First Received: August 14, 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
pediatric
epilepsy

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 23, 2014