Pediatric Epilepsy Study in Subjects 1-24 Months

Epilepsy Clinical Trial

Official title:

An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044278
• Other study ID #: LAM20007
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2002
• Last updated: January 16, 2017
• Start date: September 2000
• Est. completion date: June 2006

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

Inclusion criteria:

• Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:

• A confident diagnosis of epilepsy.

• 4 or more partial seizures per month.

• current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

• Has seizures not related to epilepsy.

• Has a surgically implanted and functioning vagal nerve stimulator.

• Has previously been treated with lamotrigine.

• Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.

• Use of experimental medication within 30 days of enrollment.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lamotrigine

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Australia	GSK Investigational Site	Parkville, Melbourne	Victoria
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	Pécs
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
Puerto Rico	GSK Investigational Site	SanJuan
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Presov
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	Buffalo	New York
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	Columbia	Missouri
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	Jonesboro	Arkansas
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	Mineola	New York
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Morristown	Tennessee
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	Salt Lake City	Utah
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,  Argentina,  Australia,  Estonia,  France,  Hungary,  Italy,  Latvia,  Lebanon,  Lithuania,  Netherlands,  Portugal,  Puerto Rico,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation		43 Months
Primary	Change from baseline in vital signs -heart rate (HR)		Up to 43 Months
Primary	Change from baseline in vital signs - weight (WT)		Up to 43 months
Primary	Change from baseline in vital signs - height (HT)		Up to 43 months
Primary	Change from baseline in vital signs - head circumference (HC)		Up to 43 months
Primary	Change from baseline in clinical chemistry parameters including Albumin and Total protein		Up to month 43
Primary	Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)		Up to 43 moths
Primary	Change from baseline in clinical chemistry parameters including total bilirubin and creatinine		Up to 43 months
Primary	Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea		Up to 43 months
Primary	Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)		Up to 43 moths
Primary	Change from baseline in Hemoglobin (Hb)		Up to 43 months
Primary	Change from baseline in Mean corpuscular hemoglobin (MCH)		Up to 43 months
Primary	Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)		Up to 43 months
Primary	Change from baseline in mean corpuscular volume (MCv)		Up to 43 months
Primary	Change from baseline in red blood cells (RBC)		Up to 43 months
Primary	Number of participants with treatment emergent neurological abnormalities		Up to 43 months
Primary	Number of participants with treatment emergent clinically significant ECG abnormalities		Up to 43 months
Primary	Number of participants with potentially clinically significant change in hematology parameters		Up to 43 months
Primary	Number of participants with potentially clinically significant change in clinical chemistry parameters		Up to 43 months
Primary	Number of participants with potentially clinically significant change in vital signs		Up to 43 months
Secondary	Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase		Up to 48 Weeks
Secondary	Investigator's assessment of the participant's overall clinical status		Up to 43 months
Secondary	Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants		Week 6

External Links

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