Pediatric Epilepsy Trial in Subjects 1-24 Months
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2000 |
| End Date: | November 2003 |
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.
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.
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).
We found this trial at
25
sites
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