Epilepsy Clinical Trial
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)
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | November 2003 |
Est. primary completion date | November 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 24 Months |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Parkville, Melbourne | Victoria |
Australia | GSK Investigational Site | Perth | Western Australia |
Australia | GSK Investigational Site | South Brisbane | Queensland |
Australia | GSK Investigational Site | West Heidleberg, Melbourne | Victoria |
Estonia | GSK Investigational Site | Tallinn | |
Estonia | GSK Investigational Site | Tartu | |
France | GSK Investigational Site | Reims Cedex | |
Hungary | GSK Investigational Site | Budapest | |
Hungary | GSK Investigational Site | Debrecen | |
Hungary | GSK Investigational Site | Miskolc | |
Hungary | GSK Investigational Site | Szeged | |
Italy | GSK Investigational Site | Bologna | Emilia-Romagna |
Italy | GSK Investigational Site | Mantova | Lombardia |
Italy | GSK Investigational Site | Messina | Sicilia |
Italy | GSK Investigational Site | Milano | Lombardia |
Italy | GSK Investigational Site | Napoli | Campania |
Italy | GSK Investigational Site | Padova | Veneto |
Latvia | GSK Investigational Site | Riga | |
Lebanon | GSK Investigational Site | Beirut | |
Lithuania | GSK Investigational Site | Kaunas | |
Netherlands | GSK Investigational Site | Groningen | |
Netherlands | GSK Investigational Site | Rotterdam | |
Netherlands | GSK Investigational Site | Utrecht | |
Portugal | GSK Investigational Site | Coimbra | |
Portugal | GSK Investigational Site | Lisboa | |
Portugal | GSK Investigational Site | Porto | |
Slovakia | GSK Investigational Site | Banska Bystrica | |
Slovakia | GSK Investigational Site | Bratislava | |
Slovakia | GSK Investigational Site | Presov | |
Spain | GSK Investigational Site | Las Palmas De Gran Canaria | |
Turkey | GSK Investigational Site | Ankara | |
United States | GSK Investigational Site | Akron | Ohio |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Augusta | Georgia |
United States | GSK Investigational Site | Chapel Hill | North Carolina |
United States | GSK Investigational Site | Charlottesville | Virginia |
United States | GSK Investigational Site | Cherry Hill | New Jersey |
United States | GSK Investigational Site | Cleveland | Ohio |
United States | GSK Investigational Site | Columbus | Ohio |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Fort Worth | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Jacksonville | Florida |
United States | GSK Investigational Site | Kansas City | Missouri |
United States | GSK Investigational Site | Lexington | Kentucky |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | Norfolk | Virginia |
United States | GSK Investigational Site | Orlando | Florida |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Richmond | Virginia |
United States | GSK Investigational Site | St. Paul | Minnesota |
United States | GSK Investigational Site | Stanford | California |
United States | GSK Investigational Site | Syracuse | New York |
United States | GSK Investigational Site | Tallahassee | Florida |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | Tucson | Arizona |
United States | GSK Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Slovakia, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. | 36 Months | No | |
Secondary | 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 | 36 Months | No |
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