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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT00043875 |
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Date of registration:
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14/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pediatric Epilepsy Trial in Subjects 1-24 Months
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Scientific title:
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A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months) |
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Date of first enrolment:
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May 2000 |
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Target sample size:
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177 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00043875 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Egypt
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Estonia
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France
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Hungary
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Italy
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Latvia
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Lebanon
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Lithuania
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Netherlands
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Portugal
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Slovakia
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Spain
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Turkey
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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).
Age minimum:
1 Month
Age maximum:
24 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: lamotrigine
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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