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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00044278