Clinical trial NCT00044278: Pediatric Epilepsy Study in Subjects 1-24 Months
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: epilepsy
pediatric
partial seizures
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-26
Enrollment: 197
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
timeFrame: 43 Months
measure: Change from baseline in vital signs -heart rate (HR)
timeFrame: Up to 43 Months
measure: Change from baseline in vital signs - weight (WT)
timeFrame: Up to 43 months
measure: Change from baseline in vital signs - height (HT)
timeFrame: Up to 43 months
measure: Change from baseline in vital signs - head circumference (HC)
timeFrame: Up to 43 months
measure: Change from baseline in clinical chemistry parameters including Albumin and Total protein
timeFrame: Up to month 43
measure: Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
timeFrame: Up to 43 moths
measure: Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
timeFrame: Up to 43 months
measure: Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
timeFrame: Up to 43 months
measure: Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
timeFrame: Up to 43 moths
measure: Change from baseline in Hemoglobin (Hb)
timeFrame: Up to 43 months
measure: Change from baseline in Mean corpuscular hemoglobin (MCH)
timeFrame: Up to 43 months
measure: Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Up to 43 months
measure: Change from baseline in mean corpuscular volume (MCv)
timeFrame: Up to 43 months
measure: Change from baseline in red blood cells (RBC)
timeFrame: Up to 43 months
measure: Number of participants with treatment emergent neurological abnormalities
timeFrame: Up to 43 months
measure: Number of participants with treatment emergent clinically significant ECG abnormalities
timeFrame: Up to 43 months
measure: Number of participants with potentially clinically significant change in hematology parameters
timeFrame: Up to 43 months
measure: Number of participants with potentially clinically significant change in clinical chemistry parameters
timeFrame: Up to 43 months
measure: Number of participants with potentially clinically significant change in vital signs
timeFrame: Up to 43 months
Secondary outcomes:
measure: Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
timeFrame: Up to 48 Weeks
measure: Investigator's assessment of the participant's overall clinical status
timeFrame: Up to 43 months
measure: Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
timeFrame: Week 6
Other outcomes:
Locations:
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
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facility: GSK Investigational Site
state: Arkansas
city: Little Rock
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facility: GSK Investigational Site
state: Arkansas
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Los Angeles
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facility: GSK Investigational Site
state: California
city: Stanford
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facility: GSK Investigational Site
state: California
city: Denver
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city: Washington
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city: Columbus
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facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
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city: Morristown
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state: Tennessee
city: Nashville
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city: Fort Worth
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state: Texas
city: Houston
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city: Salt Lake City
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state: Utah
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state: Virginia
city: Norfolk
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state: Virginia
city: Richmond
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facility: GSK Investigational Site
state: Virginia
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
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city: Parkville, Melbourne
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state: Victoria
city: Tartu
country: Estonia
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city: Reims Cedex
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Miskolc
country: Hungary
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city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Szeged
country: Hungary
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city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Mantova
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Messina
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Riga
country: Latvia
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city: Beirut
country: Lebanon
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city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Coimbra
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: SanJuan
country: Puerto Rico
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Presov
country: Slovakia
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: