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
  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 (Subject, Investigator)
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:
  • 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 ]

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)
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: August 19, 2015
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 August 27, 2015