Pediatric Epilepsy Trial in Subjects 1-24 Months

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043875
• Other study ID #: LAM20006
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2002
• Last updated: September 13, 2016
• Start date: May 2000
• Est. completion date: November 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lamotrigine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Estonia,  France,  Hungary,  Italy,  Latvia,  Lebanon,  Lithuania,  Netherlands,  Portugal,  Slovakia,  Spain,  Turkey, 

Outcome

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

External Links

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