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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00044278




Registration number
NCT00044278
Ethics application status
Date submitted
23/08/2002
Date registered
26/08/2002
Date last updated
18/01/2017

Titles & IDs
Public title
Pediatric Epilepsy Study in Subjects 1-24 Months
Scientific 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)
Secondary ID [1] 0 0
LAM20007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Timepoint [1] 0 0
43 Months
Primary outcome [2] 0 0
Change from baseline in vital signs -heart rate (HR)
Timepoint [2] 0 0
Up to 43 Months
Primary outcome [3] 0 0
Change from baseline in vital signs - weight (WT)
Timepoint [3] 0 0
Up to 43 months
Primary outcome [4] 0 0
Change from baseline in vital signs - height (HT)
Timepoint [4] 0 0
Up to 43 months
Primary outcome [5] 0 0
Change from baseline in vital signs - head circumference (HC)
Timepoint [5] 0 0
Up to 43 months
Primary outcome [6] 0 0
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Timepoint [6] 0 0
Up to month 43
Primary outcome [7] 0 0
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Timepoint [7] 0 0
Up to 43 moths
Primary outcome [8] 0 0
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Timepoint [8] 0 0
Up to 43 months
Primary outcome [9] 0 0
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Timepoint [9] 0 0
Up to 43 months
Primary outcome [10] 0 0
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Timepoint [10] 0 0
Up to 43 moths
Primary outcome [11] 0 0
Change from baseline in Hemoglobin (Hb)
Timepoint [11] 0 0
Up to 43 months
Primary outcome [12] 0 0
Change from baseline in Mean corpuscular hemoglobin (MCH)
Timepoint [12] 0 0
Up to 43 months
Primary outcome [13] 0 0
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Timepoint [13] 0 0
Up to 43 months
Primary outcome [14] 0 0
Change from baseline in mean corpuscular volume (MCv)
Timepoint [14] 0 0
Up to 43 months
Primary outcome [15] 0 0
Change from baseline in red blood cells (RBC)
Timepoint [15] 0 0
Up to 43 months
Primary outcome [16] 0 0
Number of participants with treatment emergent neurological abnormalities
Timepoint [16] 0 0
Up to 43 months
Primary outcome [17] 0 0
Number of participants with treatment emergent clinically significant ECG abnormalities
Timepoint [17] 0 0
Up to 43 months
Primary outcome [18] 0 0
Number of participants with potentially clinically significant change in hematology parameters
Timepoint [18] 0 0
Up to 43 months
Primary outcome [19] 0 0
Number of participants with potentially clinically significant change in clinical chemistry parameters
Timepoint [19] 0 0
Up to 43 months
Primary outcome [20] 0 0
Number of participants with potentially clinically significant change in vital signs
Timepoint [20] 0 0
Up to 43 months
Secondary outcome [1] 0 0
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Timepoint [1] 0 0
Up to 48 Weeks
Secondary outcome [2] 0 0
Investigator's assessment of the participant's overall clinical status
Timepoint [2] 0 0
Up to 43 months
Secondary outcome [3] 0 0
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Timepoint [3] 0 0
Week 6

Eligibility
Key inclusion 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.
Minimum age
1 Month
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2006
Sample size
Target
Accrual to date
Final
197
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Parkville, Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Parkville, Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autónoma de Buenos Aires
Country [24] 0 0
Estonia
State/province [24] 0 0
Tartu
Country [25] 0 0
France
State/province [25] 0 0
Reims Cedex
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Hungary
State/province [28] 0 0
Miskolc
Country [29] 0 0
Hungary
State/province [29] 0 0
Pécs
Country [30] 0 0
Hungary
State/province [30] 0 0
Szeged
Country [31] 0 0
Italy
State/province [31] 0 0
Campania
Country [32] 0 0
Italy
State/province [32] 0 0
Emilia-Romagna
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Sicilia
Country [35] 0 0
Italy
State/province [35] 0 0
Veneto
Country [36] 0 0
Latvia
State/province [36] 0 0
Riga
Country [37] 0 0
Lebanon
State/province [37] 0 0
Beirut
Country [38] 0 0
Lithuania
State/province [38] 0 0
Kaunas
Country [39] 0 0
Netherlands
State/province [39] 0 0
Groningen
Country [40] 0 0
Netherlands
State/province [40] 0 0
Rotterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Utrecht
Country [42] 0 0
Portugal
State/province [42] 0 0
Coimbra
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisboa
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Puerto Rico
State/province [45] 0 0
SanJuan
Country [46] 0 0
Slovakia
State/province [46] 0 0
Bratislava
Country [47] 0 0
Slovakia
State/province [47] 0 0
Presov
Country [48] 0 0
Turkey
State/province [48] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00044278
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00044278